510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2022
DEVICE: Athelas Home
Athelas Inc. 510(k) NO: K200828(Traditional)
ATTN: Tanay Tandon PHONE NO : 408 6031954
67 E Evelyn Ave. SE DECISION MADE: 22-MAR-22
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intai Anatomic Locking Plate and Screw System
Intai Technology Corporation 510(k) NO: K201229(Traditional)
ATTN: Dale Chang PHONE NO : 886 42359 5336
No. 9 Jingke Rd., Nantun Dist. SE DECISION MADE: 11-MAR-22
Taichung TW 40852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maxima Surgical Gown
Elevate Textiles 510(k) NO: K201351(Traditional)
ATTN: Nathaniel Terry PHONE NO : 336 2283009
22 American Street SE DECISION MADE: 11-MAR-22
Mt. Holly NC 28210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio Fluff System
Gnali Bocia S.R.L. 510(k) NO: K201861(Traditional)
ATTN: Katy Gnali PHONE NO :
Via Brescia, 41/M-N SE DECISION MADE: 02-MAR-22
Lumezzane IT 25065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTA SLA Dental Implant System and LOTA HA Dental Implant System
KJ Meditech Co., Ltd. 510(k) NO: K202046(Traditional)
ATTN: Hyukki Moon PHONE NO : 82 62972 5476
959-21 Daechon-dong, Buk-Gu SE DECISION MADE: 01-MAR-22
Gwang-ju KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Electric Motor
Foshan CICADA Dental Instrument Co510(k) NO: K202075(Traditional)
ATTN: Juan Liu PHONE NO : 86 757 85775667
B5-2F, Guangdong New Light Source SE DECISION MADE: 11-MAR-22
Foshan CN 528226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance Cervical IBF System
Reliance Medical Systems, LLC 510(k) NO: K202266(Traditional)
ATTN: Bret M. Berry PHONE NO : 801 2953280
545 West 500 South, Suite 100 SE DECISION MADE: 29-MAR-22
Bountiful UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infusion Sets for Single Use
Jiangsu Suyun Medical Materials Co510(k) NO: K202437(Traditional)
ATTN: Guangning Xu PHONE NO : 86 518 85608151
No.18 Jinaqiao Road, Dapu IndustriSE DECISION MADE: 25-MAR-22
Lianyungang CN 222002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InRoad® Dental Synthetic Bone Graft
Osteogene Tech Corp 510(k) NO: K202675(Traditional)
ATTN: Daniel S. Oh PHONE NO : 201 3679321
75 Oak Street SE DECISION MADE: 04-MAR-22
Norwood NJ 07648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Rizhao Sanqi Medical & Health Arti510(k) NO: K202903(Traditional)
ATTN: Julia Yu PHONE NO : 86 633 7663737
Heshan Industry park, Donggang DisSE DECISION MADE: 24-MAR-22
Rizhao CN 276823 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
Dukal Corporation 510(k) NO: K203237(Traditional)
ATTN: Megan Quevedo PHONE NO : 631 6563800 133
2 Fleetwood Court SE DECISION MADE: 18-MAR-22
Ronkonkoma NY 11779 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
Medtecs (Taiwan) Corp. 510(k) NO: K203376(Traditional)
ATTN: William Yang PHONE NO : 886 2 27392222
11F., No. 9, Songgao Road, Xinyi DSE DECISION MADE: 02-MAR-22
Taipei City TW 11073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Albumin BCP2
Abbott Ireland Diagnostics Divisio510(k) NO: K203530(Traditional)
ATTN: Suzanne Cheang PHONE NO : 972 5186617
Lisnamuck SE DECISION MADE: 18-MAR-22
Longford IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
Coloplast 510(k) NO: K203637(Traditional)
ATTN: Delaney McDougal PHONE NO : 612 3808034
1601 West River Road North SE DECISION MADE: 08-MAR-22
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qitexio
Medex 510(k) NO: K203738(Traditional)
ATTN: Sandra Thiolliere PHONE NO : 33 437 252050
240 allée Jacques Monod SE DECISION MADE: 14-MAR-22
Saint-Priest FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arterys MICA
Arterys Inc. 510(k) NO: K203744(Traditional)
ATTN: Sharon Cholowsky PHONE NO : 403 9239688
51 Federal Street, Suite 305 SE DECISION MADE: 14-MAR-22
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WatchPAT200U (WP200U)
Itamar Medical, Ltd. 510(k) NO: K203839(Traditional)
ATTN: Efrat Litman PHONE NO : 972 4 6177000
9 Halamish Street SE DECISION MADE: 21-MAR-22
Casearea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pluski Safe 1 Safety IV Catheter
Mediplus (India) Limited 510(k) NO: K210037(Traditional)
ATTN: Alka Goel PHONE NO : 91 98 18269055
1261-1262, M.I.E. Part B, BahadurgSE DECISION MADE: 25-MAR-22
Bahadurgarh IN 124507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
Fresenius Kabi AG 510(k) NO: K210073(Traditional)
ATTN: Keith Dunn PHONE NO : 224 8172430
Else-Kroner-Str. 1 SE DECISION MADE: 01-MAR-22
Bad Homburg DE 61346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
Fresenius Kabi AG 510(k) NO: K210074(Traditional)
ATTN: Keith Dunn PHONE NO : 224 8172430
Else-Kroner-Str. 1 SE DECISION MADE: 01-MAR-22
Bad Homburg DE 61346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vigilant Software Suite – Vigilant Master Med
Fresenius Kabi AG 510(k) NO: K210075(Traditional)
ATTN: Keith Dunn PHONE NO : 224 8172430
Else-Kroner-Str. 1 SE DECISION MADE: 01-MAR-22
Bad Homburg DE 61346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digimamo D
VMI Tecnologias LTDA 510(k) NO: K210151(Traditional)
ATTN: Siele Santos PHONE NO : 55 31 36816388
Rua Prefeito Elizeu Alves Da SilvaSE DECISION MADE: 01-MAR-22
Lagoa Santa BR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
Sichuan YOUKEDE Medical Equipment 510(k) NO: K210171(Traditional)
ATTN: Sukey Chia PHONE NO : 86 0816 2296641
2F, North Wing, No.102 Building, MSE DECISION MADE: 18-MAR-22
Mianyang CN 621000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Automatically Retractable Insulin Safety Syringe
Shantou Wealy Medical Instrument C510(k) NO: K210216(Traditional)
ATTN: Yuhe Yang PHONE NO : 86 754 82121967
North Jinhuan Road SE DECISION MADE: 04-MAR-22
Shantou CN 515064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps
Modern Medical Equipment Manufactu510(k) NO: K210315(Traditional)
ATTN: Jerry Cheung PHONE NO : 852 24209068
Flat A, 11/F., Mai Wah Ind. Bldg.,SE DECISION MADE: 17-MAR-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dukal Corporation Level 1 Pediatric Face Mask
Dukal Corporation 510(k) NO: K210321(Traditional)
ATTN: Megan Quevedo PHONE NO : 631 6563800 133
2 Fleetwood Court SE DECISION MADE: 29-MAR-22
Ronkonkoma NY 11779 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
WRP Asia Pacific SDN BHD 510(k) NO: K210330(Traditional)
ATTN: Zahari Bin Darus PHONE NO : 60 387 061486
Lot 1, Jalan 3, Kaw Perusahaan BanSE DECISION MADE: 04-MAR-22
Sepang MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: One Step Pregnancy Test
SPD Swiss Precision Diagnostics Gm510(k) NO: K210341(Traditional)
ATTN: Joanne Scaife PHONE NO : 41 580 047345
47 Route de Saint Georges, Petit-LSE DECISION MADE: 10-MAR-22
Geneva CH CH-1213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GGM Breathing Circuit Bacterial Filter
Great Group Medical Co., Ltd. 510(k) NO: K210352(Traditional)
ATTN: Kiki Hung PHONE NO : 886 4 8758181
No. 168, Xingong 2nd Rd., TianzhonSE DECISION MADE: 27-MAR-22
Changhua County TW 520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Second Opinion
Pearl Inc. 510(k) NO: K210365(Traditional)
ATTN: Bill Birdsall PHONE NO : 239 4508829
2515 Benedict Canyon Drive SE DECISION MADE: 04-MAR-22
Beverly Hills CA 90210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-Laser Blue, D-Laser 16
Guilin Woodpecker Medical Instrume510(k) NO: K210367(Traditional)
ATTN: Yang Yunfeng PHONE NO : 86 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 10-MAR-22
Guilin CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTAI Surgical Mask (non-sterile)
INTAI Technology Corp. 510(k) NO: K210422(Traditional)
ATTN: Dale Chang PHONE NO :
No. 9, Jingke Rd., SE DECISION MADE: 30-MAR-22
Nantun Dist. TW 40852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Creatinine2
Abbott Ireland Diagnostics Divisio510(k) NO: K210452(Traditional)
ATTN: Magdalena Suszko PHONE NO : 224 6679025
Lisnamuck SE DECISION MADE: 22-MAR-22
Longford IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICtapered & SICvantage tapered
SIC invent AG 510(k) NO: K210489(Traditional)
ATTN: Cretia Arlene McNett PHONE NO : 49 551 50429440
Birmannsgasse 3 SE DECISION MADE: 17-MAR-22
Basel CH CH-4055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
Millennium Medical Technologies In510(k) NO: K210528(Traditional)
ATTN: Wangzhong Sheng PHONE NO : 949 2158560
6352 Corte de Abeto, Suite A SE DECISION MADE: 16-MAR-22
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics 510(k) NO: K210546(Traditional)
ATTN: Jane Phillips PHONE NO : 317 5213338
9115 Hague Road SE DECISION MADE: 31-MAR-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEXR PLUS
GMV S.r.l. 510(k) NO: K210693(Traditional)
ATTN: Andrea Cancelli PHONE NO : 39 069 4315964
Via Roberto Parabeni 37 SE DECISION MADE: 22-MAR-22
Rome IT 00173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
Huizhou Foryou Medical Devices Co.510(k) NO: K210718(Traditional)
ATTN: Junfeng Zhang PHONE NO : 86 0752 5302185
North Shangxia Rd, Dongjiang Hi-teSE DECISION MADE: 23-MAR-22
Huizhou CN 516005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynamyx Digital Pathology Software
Inspirata, Inc. 510(k) NO: K210811(Traditional)
ATTN: Richard Morroney PHONE NO : 813 5708900
One North Dale Mabry Hwy Suite 600SE DECISION MADE: 01-MAR-22
Tampa FL 33609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYMA Laser
LYMA Life Ltd. 510(k) NO: K210823(Traditional)
ATTN: Simon Goff PHONE NO : 44 7950 396247
93 Gloucester Place SE DECISION MADE: 18-MAR-22
London GB W1H 6JQ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sure-Fine Insulin Syringes
Shina Med Corporation 510(k) NO: K210848(Special)
ATTN: Jeong Ho Ryu PHONE NO : 82 31 80572125
455-30, Bogaewonsam-ro Bogae-myeonSE DECISION MADE: 01-MAR-22
Anseong-si KR 17509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Southern Implants Instrument Trays
Southern Implants (Pty) Ltd 510(k) NO: K210923(Traditional)
ATTN: Lauranda G Breytenbach PHONE NO : 27 12 6671046
1 Albert Road SE DECISION MADE: 02-MAR-22
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alexis Contained Extraction System
Applied Medical Resources Corporat510(k) NO: K211043(Traditional)
ATTN: Apeksha Shanbhag PHONE NO : 949 7138341
22872 Avenida Empresa SE DECISION MADE: 31-MAR-22
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERIC Retrieval Device
MicroVention Inc. 510(k) NO: K211120(Traditional)
ATTN: Stephanie Onstot PHONE NO : 714 2478000 8317
35 Enterprise SE DECISION MADE: 31-MAR-22
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARISTE AB Mesh
Ariste Medical LLC 510(k) NO: K211132(Traditional)
ATTN: Olaf Schulz PHONE NO : 901 7341303
9950 S 300 W SE DECISION MADE: 18-MAR-22
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
Stryker Sustainability Solutions 510(k) NO: K211138(Traditional)
ATTN: Mia Brown PHONE NO : 480 3431855
1810 West Drake Drive SE DECISION MADE: 08-MAR-22
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2329 Adult O2 Transducer)
Stryker Sustainability Solutions 510(k) NO: K211140(Traditional)
ATTN: Moira Barton-Varty PHONE NO : 602 4100204
1810 West Drake Drive SE DECISION MADE: 08-MAR-22
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto CPAP System
BMC Medical Co., Ltd. 510(k) NO: K211155(Traditional)
ATTN: Amy Wang PHONE NO : 86 010 51663880
Room 901, Building 1, No. 28 PinggSE DECISION MADE: 09-MAR-22
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sugita AVM Microclips
Mizuho America, Inc. 510(k) NO: K211183(Traditional)
ATTN: Richard Chadwick PHONE NO : 510 3244500 150
30057 Ahern Avenue SE DECISION MADE: 02-MAR-22
Union City CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.4mm Distal Radius System
Auxein Medical Private Limited 510(k) NO: K211324(Traditional)
ATTN: Gaurav Luthra PHONE NO : 91 971 7586969
Plot No 168-169-170 Sector 57, PhaSE DECISION MADE: 14-MAR-22
Sonepat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alio Medical Remote Monitoring System
Graftworx, Inc. dba Alio 510(k) NO: K211365(Traditional)
ATTN: David Kuraguntla PHONE NO : 650 4408483
544B Bryant Street SE DECISION MADE: 24-MAR-22
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stasis Gel
Belport Company, Inc., Gingi-Pak 510(k) NO: K211420(Traditional)
ATTN: Mohammed Islam PHONE NO : 805 7644468
4825 Calle Alto SE DECISION MADE: 14-MAR-22
Camarillo CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTRELL Mapping Catheter with TRUEref Technology
Biosense Webster, Inc. 510(k) NO: K211438(Traditional)
ATTN: John Jimenez PHONE NO : 949 9234774
31 Technology Drive Suite 200 SE DECISION MADE: 18-MAR-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles
Shinva Ande Healthcare Apparatus C510(k) NO: K211484(Traditional)
ATTN: Xiaolei Tian PHONE NO : 86 0533 3917821
No.77 Development Zone North Road,SE DECISION MADE: 01-MAR-22
Zibo CN 255086 510(k) STATEMENT
DEVICE: BTL-785W
BTL Industries Inc. 510(k) NO: K211639(Traditional)
ATTN: David Chmel PHONE NO : 866 2851656
362 Elm Street SE DECISION MADE: 07-MAR-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
NORAS MRI products GmbH 510(k) NO: K211658(Traditional)
ATTN: Manuel Noras PHONE NO : 49 931 2992729
Leibnizstr. 4 SE DECISION MADE: 03-MAR-22
Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EON
Dominion Aesthetic Technologies, I510(k) NO: K211681(Traditional)
ATTN: Ahmed Mohammed PHONE NO : 763 4394602
2431 Aloma Avenue Suite 225 SE DECISION MADE: 30-MAR-22
Winter Park FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
Microlife Intellectual Property Gm510(k) NO: K211776(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277000
Espenstrasse 139 SE DECISION MADE: 01-MAR-22
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEN-2090 Turbo
Genoray Co., Ltd. 510(k) NO: K211780(Traditional)
ATTN: Sookyung Choi PHONE NO : 82 31 51785769
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 09-MAR-22
Seongnam-si KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemoclip
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K211787(Traditional)
ATTN: Yanping Fu PHONE NO : 86 571 87671223
Building 5, Building 6, No. 597 KaSE DECISION MADE: 03-MAR-22
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GoBack Crossing Catheter
Upstream Peripheral Technologies, 510(k) NO: K211802(Traditional)
ATTN: Dan Rottenberg PHONE NO : 972 4 6239014
ARAN Building, P.O. Box 3067; 43 HSE DECISION MADE: 01-MAR-22
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Dongguan Grinvald Technology Co., 510(k) NO: K211808(Traditional)
ATTN: Anna Roxana Grinvald PHONE NO : 86 0769 23326470
401, Building #3 No 4 of GuangmingSE DECISION MADE: 04-MAR-22
Dongguan CN 52300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
Wuxi Beien Surgery Device Co., Ltd510(k) NO: K211811(Traditional)
ATTN: Juan Li PHONE NO : 86 177 14968073
No.99 Furong San Road SE DECISION MADE: 03-MAR-22
Wuxi CN 214192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PolyLock Plating System
Fusion Orthopedics 510(k) NO: K211843(Traditional)
ATTN: Eli Jacobson PHONE NO : 800 4036876
4135 S Powder Road SE DECISION MADE: 04-MAR-22
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Leg Massager (model: FE-7204B)
Xiamen Healthpal Electronic Co.,Lt510(k) NO: K211850(Traditional)
ATTN: Henry Zhang PHONE NO : 86 592 5326750
No.170 Siming Park Tongan DistrictSE DECISION MADE: 03-MAR-22
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYAH
VISIA imaging S.R.L. 510(k) NO: K211868(Traditional)
ATTN: Alessia Magnanini PHONE NO : 39 055 9121635
Via Martiri della Libertà, 95/e SE DECISION MADE: 01-MAR-22
San Giovanni Valdarno IT 52027 510(k) STATEMENT
DEVICE: Minuteman G5 MIS Fusion Plate
Spinal Simplicity LLC 510(k) NO: K211880(Traditional)
ATTN: Adam Rogers PHONE NO : 913 4514414
6600 College Blvd, Ste 220 SE DECISION MADE: 11-MAR-22
Overland Park KS 66211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Personal Kinetigraph (PKG) System Gen 2 Plus
GKC Manufacturing Pty Ltd 510(k) NO: K211887(Traditional)
ATTN: Jim Quackenbush PHONE NO : 612 819 5478
Level 9, 31 Queen Street SE DECISION MADE: 11-MAR-22
Melbourne AU 3000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Information Center iX
Philips Medizin Systeme Böblingen 510(k) NO: K211900(Traditional)
ATTN: Peng Cui PHONE NO : 978 494 9840
Hewlett-Packard Str.2 SE DECISION MADE: 04-MAR-22
Böblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Coloplast Corp 510(k) NO: K211911(Traditional)
ATTN: Angela Kilian PHONE NO : 612 2874236
1601 West River Road North SE DECISION MADE: 10-MAR-22
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
Kinetic Innovative Seating System 510(k) NO: K211919(Traditional)
ATTN: Susan Farricielli PHONE NO : 203 4881758
26 N. Main Street, Office Bldg SE DECISION MADE: 04-MAR-22
Branford CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SancDam Latex Oral Dam
Sanctuary Health Sdn. Bhd. 510(k) NO: K212037(Traditional)
ATTN: Sumethi Selavaraju PHONE NO : 605 201 2800 204
No. 16, Persiaran Perindustrian KaSE DECISION MADE: 28-MAR-22
Chemor MY 31200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RI.HIP MODELER
Blue Belt Technologies, Inc. 510(k) NO: K212040(Traditional)
ATTN: Michael Gosha PHONE NO : 216 8166728 4135
2905 Northwest Boulevard, Suite 40SE DECISION MADE: 11-MAR-22
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oclet TDS 1000
TendoNova Corporation 510(k) NO: K212049(Traditional)
ATTN: Mark Samuels PHONE NO : 404 3766726
3050 Business Park Drive, Suite A-SE DECISION MADE: 08-MAR-22
Norcross GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
ArtVentive Medical Group, Inc. 510(k) NO: K212057(Traditional)
ATTN: Anil Bhalani PHONE NO : 949 7776749
1797 Playa Vista SE DECISION MADE: 01-MAR-22
San Marcos CA 92708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products LLC 510(k) NO: K212148(Traditional)
ATTN: Donald Cronk PHONE NO : 1 775 4707106
2301 Robb Drive SE DECISION MADE: 10-MAR-22
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyndMove 2.0
MyndTec Inc. 510(k) NO: K212149(Traditional)
ATTN: Yesmil Pena PHONE NO :
1900 Minnesota Court Suite 122 SE DECISION MADE: 03-MAR-22
Mississauga CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biobeat Platform, BB-613WP Patch
BioBeat Technologies Ltd. 510(k) NO: K212153(Traditional)
ATTN: Johanan May PHONE NO : 972 3 9333022
26 Ha'magshimim Street SE DECISION MADE: 25-MAR-22
Petah Tikvah IL 4934835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shield System
Radiaction Ltd. 510(k) NO: K212159(Traditional)
ATTN: Jonathan Yifat PHONE NO : 972 54 7257565
10 Hanechoshet St. SE DECISION MADE: 30-MAR-22
Tel Aviv IL 69710 510(k) STATEMENT
DEVICE: Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
Innovative Health, LLC. 510(k) NO: K212165(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 10-MAR-22
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restoration® Modular Hip System
Howmedica Osteonics Corp., dba Str510(k) NO: K212187(Traditional)
ATTN: Margaret Klippel PHONE NO : 201 8315559
325 Corporate Dr. SE DECISION MADE: 01-MAR-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K212231(Traditional)
ATTN: Donny Lee PHONE NO : 0086 25 83305050
8A, Block 1. No. 301, Hanzhongmen SE DECISION MADE: 25-MAR-22
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luna G3 BPAP System
3B Medical, Inc. 510(k) NO: K212263(Traditional)
ATTN: Yasser Estafanous PHONE NO : 863 2266285
203 Avenue A NW, Suite 300 SE DECISION MADE: 25-MAR-22
Winter Haven FL 33881 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Trays
Dentsply Sirona Inc. 510(k) NO: K212281(Traditional)
ATTN: Courtney Clark PHONE NO : 248 8954379
221 West Philadelphia Street, SuitSE DECISION MADE: 04-MAR-22
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yadu Medical Face Mask (Level 1)
HeNan YADU Industrial Co., Ltd. 510(k) NO: K212330(Traditional)
ATTN: Charles Shen PHONE NO : 608 217 9358
No. 234 West Jianpu Road SE DECISION MADE: 14-MAR-22
Changyuan CN 453400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Equinoxe® Laser Cage Glenoid
Exactech, Inc. 510(k) NO: K212356(Traditional)
ATTN: Kenneth C. Maxwell PHONE NO : 352 3771140
2320 NW 66th Ct. SE DECISION MADE: 04-MAR-22
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BoneView
Gleamer 510(k) NO: K212365(Traditional)
ATTN: Antoine Tournier PHONE NO : 33 615 812345
5 Avenue du Général de Gaulle SE DECISION MADE: 01-MAR-22
Saint Mandé FR 94160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Evora Full Face Mask
Fisher & Paykel Healthcare Ltd 510(k) NO: K212371(Traditional)
ATTN: Reena Daken PHONE NO : 64 9 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 18-MAR-22
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Pro510(k) NO: K212379(Traditional)
ATTN: Martina Pfeiff PHONE NO : 49 174 3319336
Emil-von-Behring Str. 76 SE DECISION MADE: 02-MAR-22
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPN NC PTCA Dilatation Catheter
SIS Medical AG 510(k) NO: K212393(Traditional)
ATTN: Sergej Kammerzell PHONE NO :
Hugerbüelstrasse 12 a SE DECISION MADE: 14-MAR-22
Frauenfeld CH CH-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nebulizer
Shenzhen Homed Medical Device Co.,510(k) NO: K212395(Traditional)
ATTN: Shi Shengming PHONE NO : 86 755 29821671
3rd Floor, Block 1, Longquan IndusSE DECISION MADE: 25-MAR-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK MS PRIME
bioMerieux, Inc. 510(k) NO: K212461(Traditional)
ATTN: Nathan Hardesty PHONE NO : 314 7318666
595 Anglum Rd. SE DECISION MADE: 15-MAR-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dukal Corporation AAMI Level 4 Open-Back Protective Gown
Dukal Corporation 510(k) NO: K212464(Traditional)
ATTN: Megan Quevedo PHONE NO : 631 6563800 133
2 Fleetwood Court SE DECISION MADE: 30-MAR-22
Ronkonkoma NY 11779 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stable-L Standalone Lumbar Interbody System
Nexus Spine, LLC 510(k) NO: K212498(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7028592
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 18-MAR-22
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Insulin Syringe (0.3mL)
Becton, Dickinson and Company 510(k) NO: K212499(Traditional)
ATTN: Mark William PHONE NO : 732 5275008
1 Becton Drive SE DECISION MADE: 09-MAR-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Surgical Gloves Powder Free
Amazing Rubber Products Pvt Ltd 510(k) NO: K212596(Abbreviated)
ATTN: Jayasankar S PHONE NO : 94 47 053062
Plot No 14c, Cochin Special EconomSE DECISION MADE: 01-MAR-22
Cochin IN 682037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healgen Strep A Rapid Test Strip (Throat Swab)
Healgen Scientific, LLC 510(k) NO: K212623(Traditional)
ATTN: Jianqiu Fang PHONE NO : 713 7338088
5213 Maple St SE DECISION MADE: 16-MAR-22
Bellaire TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathBuilder Transseptal Needle
Shanghai MicroPort EP MedTech Co.,510(k) NO: K212625(Traditional)
ATTN: Tian Xia PHONE NO : 86 21 38954600 3613
Building 23&28, Lane 588, TianxionSE DECISION MADE: 23-MAR-22
Shanghai CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathBuilder Transseptal Guiding Introducer
Shanghai MicroPort EP MedTech Co.,510(k) NO: K212626(Traditional)
ATTN: Tian Xia PHONE NO : 86 21 38954600 3613
Building 23&28, Lane 588, TianxionSE DECISION MADE: 23-MAR-22
Shanghai CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K212628(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 11-MAR-22
Barberá del Vallés ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
Contamac Ltd. 510(k) NO: K212631(Traditional)
ATTN: Rob McGregor PHONE NO : 44 1799 542000
Carlton House Shire Hill SE DECISION MADE: 17-MAR-22
Saffron Walden GB CB11 3AU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe with Fixed Safety Needle for Single Use
Gemtier Medical (Shanghai) Inc. 510(k) NO: K212652(Traditional)
ATTN: Lenny Cao PHONE NO : 86 21 67360886
No.18 Jianding Road, Fengjing TownSE DECISION MADE: 02-MAR-22
Shanghai CN 201502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osteon Precision Milled Suprastructure
Implant Solutions PTY LTD (Osteon 510(k) NO: K212676(Traditional)
ATTN: Andrea Del Ciotto PHONE NO : 61 408 583222
759-767 Springvale Road SE DECISION MADE: 03-MAR-22
Mulgrave AU 3170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plus Medical Isolation Gown Level 3
Foshan Nanhai Plus Medical Co Ltd 510(k) NO: K212698(Traditional)
ATTN: Eric Li PHONE NO : 86 0757 86914198
Shatou Jiujiang Town, Nanhai DistrSE DECISION MADE: 02-MAR-22
Foshan CN 528208 510(k) STATEMENT
DEVICE: VoqX Electronic Stethoscope
Sanolla Ltd. 510(k) NO: K212709(Traditional)
ATTN: Doron Adler PHONE NO : 972 54 5705602
19 Ha'Mesilla Street SE DECISION MADE: 15-MAR-22
Nesher IL 3688519 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: nordicDSC
NordicNeurolab AS 510(k) NO: K212720(Traditional)
ATTN: Chandana Gurung Bhandari PHONE NO : 47 55 707095
Moellendalsveien 1 SE DECISION MADE: 03-MAR-22
Bergen NO 5009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-995-rTMS
BTL Industries Inc. 510(k) NO: K212723(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 04-MAR-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Surgical Mask
Hubei Huaqiang High-Tech Co., Ltd.510(k) NO: K212726(Traditional)
ATTN: Jing Yang PHONE NO : 86 135 45751006
No.499 DongLin Road SE DECISION MADE: 23-MAR-22
Yichang CN 443000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNUS SACRONAIL® Transsacral Stabilization System
SIGNUS Medizintechnik GmbH 510(k) NO: K212755(Traditional)
ATTN: Holger Noss PHONE NO : 049 6023 91660
Industriestrasse 2 SE DECISION MADE: 10-MAR-22
Alzenau DE 63755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoSK and EchoSGyn modules for EchoS Family devices
Echolight S.p.A 510(k) NO: K212851(Traditional)
ATTN: Giuseppe Criscenti PHONE NO : 39 083 21592607
Via Raffaello Sanzio, 18 SE DECISION MADE: 16-MAR-22
Lecce IT 73100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Golnit Nylon Monofilament Suture
Antarma LLC dba Golnit Sutures 510(k) NO: K212888(Abbreviated)
ATTN: Armine Badalyan PHONE NO : 718 2190731
276 5th Ave., Suite 704 SE DECISION MADE: 31-MAR-22
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syngo.CT Dual Energy
Siemens Medical Solutions USA Inc.510(k) NO: K212889(Traditional)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 28-MAR-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempSure System
Cynosure, LLC 510(k) NO: K212891(Traditional)
ATTN: Michael King PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 18-MAR-22
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PhasTIPP
LeMaitre Vascular Inc. 510(k) NO: K212894(Traditional)
ATTN: Anurag Gadgil PHONE NO : 781 3621277
63 Second Ave SE DECISION MADE: 31-MAR-22
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Rimba Glove SDN BHD 510(k) NO: K212916(Traditional)
ATTN: Zahari Bin Darus PHONE NO : 605 5483688
Plot 37, Medan Tasek, Tasek IndustSE DECISION MADE: 24-MAR-22
IPOH MY 31400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
Shandong Weigao Group Medical Poly510(k) NO: K212920(Traditional)
ATTN: Lina Liu PHONE NO : 86 631 5716818
No.18 Xingshan Road, Torch Hi-techSE DECISION MADE: 11-MAR-22
Weihai CN 264210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vintage Prime Press
Shofu Dental Corporation 510(k) NO: K212939(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277 202
1225 Stone Drive SE DECISION MADE: 18-MAR-22
San Marcos CA 92078 510(k) STATEMENT
DEVICE: Skanmobile, Skanmobile-Dr
Skanray Technologies Limited 510(k) NO: K212940(Traditional)
ATTN: Vasundhara R PHONE NO : 9 182 12415559
Plot# 15-17, Hebbal Industrial AreSE DECISION MADE: 04-MAR-22
Mysore IN 570016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Disposable Temperature Probe
Shenzhen Envisen Industry Co., Ltd510(k) NO: K212945(Traditional)
ATTN: Ailsa Huang PHONE NO : 86 0755 88827227
Block 1, Room 201, 301, 401, 40 JiSE DECISION MADE: 01-MAR-22
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fit Pro Breast Pump
Hygeia II Medical Group, Inc. 510(k) NO: K212955(Traditional)
ATTN: Brett Nakfoor PHONE NO : 714 515 7571
6241 Yarrow Drive SE DECISION MADE: 15-MAR-22
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation 510(k) NO: K212960(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 22-MAR-22
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smile-100 System
Niramai Health Analytix Private Li510(k) NO: K212965(Traditional)
ATTN: Geetha Manjunath PHONE NO : 91 988 0118379
Innova Pearl, Ground Floor, No.17,SE DECISION MADE: 10-MAR-22
Bangalore IN 560095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Functional Electrosurgical Knife
Anrei Medical (Hangzhou) Co., Ltd.510(k) NO: K212999(Traditional)
ATTN: Huibing Yang PHONE NO : 86 571 86913333 8658
No. 3 Ave 8, HEDA SE DECISION MADE: 21-MAR-22
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apollo Ankle Fracture Plating System
GLW Medical Inc 510(k) NO: K213005(Traditional)
ATTN: Arundhati Radhakrishnan PHONE NO : 201 2683281
300 Sylvan Ave SE DECISION MADE: 11-MAR-22
Englewood Cliff NJ 07632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer, model: HS-9802D
Jiaxing Shangjia Intelligence Tech510(k) NO: K213038(Traditional)
ATTN: Lou Yongwei PHONE NO : 86 0573 89978800
Room 102 & 202, Building No. 9, JiSE DECISION MADE: 10-MAR-22
Jiaxing CN 314000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K213121(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 15-MAR-22
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReNew Disposable Scissor Tips
Microline Surgical, Inc. 510(k) NO: K213127(Traditional)
ATTN: Scott Marchand Davis PHONE NO : 978 867 1758
50 Dunham Road, Suite 1500 SE DECISION MADE: 02-MAR-22
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
Chirurgie Innovation 510(k) NO: K213135(Special)
ATTN: Guillaume Noury PHONE NO : 33 169 203021
Z.A. Les Godets, 3 Rue Des Petits SE DECISION MADE: 02-MAR-22
Verriere le Buisson FR 91370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERABIEN MiLai
Kuraray Noritake Dental Inc. 510(k) NO: K213147(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011736
Tokiwabashi Tower, 2-6-4, OtemachiSE DECISION MADE: 28-MAR-22
Chiyoda-ku JP 100-0004 510(k) STATEMENT
DEVICE: Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co., Ltd 510(k) NO: K213189(Traditional)
ATTN: Dandan Huang PHONE NO : 86 571 81957767
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 01-MAR-22
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solus Gold Embolization Device
Artio Medical, Inc. 510(k) NO: K213200(Traditional)
ATTN: Erdie De Peralta PHONE NO : 978 4080949
127 Independence Drive SE DECISION MADE: 21-MAR-22
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
Medtronic Xomed, Inc. 510(k) NO: K213246(Traditional)
ATTN: Alexandra Oliver PHONE NO : 904 3328936
6743 Southpoint Drive North SE DECISION MADE: 21-MAR-22
Jacksonville FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovaGuide 2 Intelligent Ultrasound
NovaSignal Corporation 510(k) NO: K213279(Traditional)
ATTN: Raajdeep (Raaj) Venkatesan PHONE NO : 323 2524762
2440 S. Sepulveda Blvd., Ste 115 SE DECISION MADE: 02-MAR-22
Los Angeles CA 90064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: easy Claire
Y & J Bio Co., Ltd. 510(k) NO: K213285(Traditional)
ATTN: Chun Young Sam PHONE NO : 82 031 51803490
B-916, 947, Hanam-daero SE DECISION MADE: 03-MAR-22
Hanam-si KR 12982 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CerusEndo Microcatheter (027)
Cerus Endovascular, Inc. 510(k) NO: K213314(Traditional)
ATTN: Lori Adels PHONE NO : 1 510 6514000 109
47757 Fremont Blvd SE DECISION MADE: 15-MAR-22
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart
ConMed Corporation 510(k) NO: K213354(Traditional)
ATTN: Lisa Anderson PHONE NO : 94 1 7132035
525 French Road SE DECISION MADE: 11-MAR-22
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Toro-L Interbody Fusion System
Integrity Implants Inc. 510(k) NO: K213355(Traditional)
ATTN: Alexa Kamer PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 25-MAR-22
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Shenzhen SafeSecure Medical Infect510(k) NO: K213358(Traditional)
ATTN: Patty Chen PHONE NO : 0086 755 27040468
6A01, Block 1, Ahoke Plaza, DalingSE DECISION MADE: 04-MAR-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIQA
PTW-Freiburg Physikalisch-Technisc510(k) NO: K213370(Traditional)
ATTN: Sandor-Csaba Ats PHONE NO : 49 761 49055896
Dr. Pychlau GmbH Loerracher StrassSE DECISION MADE: 30-MAR-22
Freiburg DE 79102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Smart Glove Corporation Sdn.Bhd. 510(k) NO: K213373(Traditional)
ATTN: Lim Chin Keong PHONE NO : 603 32916100
Lot 6487, Batu 5 3/4 Sementa, JalaSE DECISION MADE: 10-MAR-22
Klang MY 42100 510(k) STATEMENT
DEVICE: Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
RB Health (US) 510(k) NO: K213400(Traditional)
ATTN: Lisa Burns PHONE NO : 862 3250012
399 Interpace Parkway SE DECISION MADE: 01-MAR-22
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber Suture Anchor
OSSIO Ltd. 510(k) NO: K213415(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 28-MAR-22
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elation Pulmonary Balloon Dilation Catheter
Merit Medical Systems, Inc. 510(k) NO: K213434(Traditional)
ATTN: David Thomas PHONE NO : 801 3164956
1600 West Merit Parkway SE DECISION MADE: 08-MAR-22
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathLoc Lumbar Interbody Fusion Cage System
L&K BioMed Co., Ltd. 510(k) NO: K213441(Traditional)
ATTN: Kang-Keun Lee PHONE NO : 82 2 67171983
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 09-MAR-22
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
Ureteral Stent Company 510(k) NO: K213444(Traditional)
ATTN: Mike Bunker PHONE NO : 216 2588047
45 Glenridge Court SE DECISION MADE: 17-MAR-22
Chagrin Falls OH 44022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
Fort Defiance Industries LLC 510(k) NO: K213457(Abbreviated)
ATTN: Chris Coleman PHONE NO : 865 6576108
2411 Maremont Parkway SE DECISION MADE: 02-MAR-22
Loudon TN 37774 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AviClear Laser System
Cutera, Inc. 510(k) NO: K213461(Traditional)
ATTN: Amogh Kothare PHONE NO : 415 6575730
3240 Bayshore Blvd. SE DECISION MADE: 24-MAR-22
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLP systems Track
Abbott Laboratories 510(k) NO: K213486(Traditional)
ATTN: Michele Smith Waheed PHONE NO : 972 5187645
100 Abbott Park Rd. SE DECISION MADE: 10-MAR-22
Abbott Park IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dib UltraNav Transseptal Catheter System
Dib UltraNav Medical, LLC 510(k) NO: K213492(Traditional)
ATTN: Lowry Barfield PHONE NO : 602 7142813
123 W. Mills Avenue STE 600 SE DECISION MADE: 24-MAR-22
El Paso TX 79901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Philips Medical Systems Nederland,510(k) NO: K213516(Abbreviated)
ATTN: Jan van de Kerkhof PHONE NO : 31 613300542
Veenpluis 4-6 SE DECISION MADE: 03-MAR-22
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSafe Pre-Filled Normal Saline Flush Syringe
Amsino International, Inc. 510(k) NO: K213522(Traditional)
ATTN: Jane Gao PHONE NO : 86 139 16147664
708 Corporate Center Drive SE DECISION MADE: 22-MAR-22
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus HD 43 Detector
iRay Technology Taicang Ltd. 510(k) NO: K213529(Special)
ATTN: Junjie Qian PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 29-MAR-22
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHantom Trilogy
Resurgeonz LLC 510(k) NO: K213534(Traditional)
ATTN: Julie LaLonde PHONE NO : 407 2336292
1550 Monte Carlo Court SE DECISION MADE: 11-MAR-22
Merritt Island FL 32952 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Giraffe Omnibed Carestation CS1
Datex Ohmeda Inc. 510(k) NO: K213551(Traditional)
ATTN: Shiwani Zalpuri PHONE NO : 91 987 1090801
9900 Innovation Drive SE DECISION MADE: 02-MAR-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Giraffe Incubator Carestation CS1
Datex Ohmeda Inc. 510(k) NO: K213553(Traditional)
ATTN: Shiwani Zalpuri PHONE NO : 91 987 1090801
9900 Innovation Drive SE DECISION MADE: 02-MAR-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device
Ulike Co., Ltd 510(k) NO: K213558(Traditional)
ATTN: Lin Xiaoming PHONE NO : 86 159 15373017
2, Myeongdong, 6-gil, Jung-gu SE DECISION MADE: 08-MAR-22
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DTX Studio Clinic 3.0
Nobel Biocare AB 510(k) NO: K213562(Traditional)
ATTN: Wim Vrydag PHONE NO : 32 15 443200
Vastra Hamngatan 1 SE DECISION MADE: 25-MAR-22
411 17 Goteborg SE 402 26 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Radial Head Replacement System
DePuy Synthes 510(k) NO: K213563(Traditional)
ATTN: Quinn McCarthy PHONE NO : 732 9472251
1301 Goshen Parkway SE DECISION MADE: 18-MAR-22
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearRead Xray Pneumothorax
Riverain Technologies, Inc. 510(k) NO: K213566(Traditional)
ATTN: Jonathan Jackson PHONE NO : 937 5315092
3020 South Tech Blvd. SE DECISION MADE: 10-MAR-22
Miamisburg OH 45342-4860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE Calcaneal Fracture Plating System
Medline Industries, LP 510(k) NO: K213567(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 02-MAR-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX-Rise Mobile X-ray System
Carestream Health 510(k) NO: K213568(Traditional)
ATTN: Gina Maiolo PHONE NO : 516 3950597
150 Verona St SE DECISION MADE: 23-MAR-22
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
FONA S.r.l 510(k) NO: K213579(Traditional)
ATTN: Luigi Germano PHONE NO : 39 02 45712171
Via G.Galilei 11 SE DECISION MADE: 02-MAR-22
Assago IT 20057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUBUKI XF Neurovascular Long Sheath
Asahi Intecc Co., Ltd. 510(k) NO: K213589(Traditional)
ATTN: Tomoya Eguchi PHONE NO : 81 561 561859
3-100 Akatsuki-cho SE DECISION MADE: 24-MAR-22
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Topaz Sacroiliac Screw System
Osseus Fusion Systems, LLC 510(k) NO: K213590(Traditional)
ATTN: Jonathan Rosen PHONE NO : 407 4975263
1931 Greenville Ave, Suite 200 SE DECISION MADE: 01-MAR-22
Dallas TX 75206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iridex 810 Laser
Iridex Corporation 510(k) NO: K213592(Special)
ATTN: Bill Hyatt PHONE NO : 650 9404700
1212 Terra Bella Ave. SE DECISION MADE: 23-MAR-22
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shoulder Innovations Total Shoulder System
Shoulder Innovations, Inc. 510(k) NO: K213615(Traditional)
ATTN: Don Running PHONE NO : 574 2531133
13827 Port Sheldon Street SE DECISION MADE: 11-MAR-22
Holland MI 49424 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Surgiphor Antimicrobial Irrigation System
Becton, Dickinson and Company 510(k) NO: K213616(Traditional)
ATTN: Shelley Wilcox PHONE NO : 303 3243816
75 N Fairway Dr SE DECISION MADE: 23-MAR-22
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTEAR100 Neurostimulator
Olympic Ophthalmics 510(k) NO: K213623(Traditional)
ATTN: Michael Gertner PHONE NO : 650 2839388
400 NW Gilman Blvd no 1370 SE DECISION MADE: 16-MAR-22
Issaquah WA 98027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus HD 35 Detector
iRay Technology Taicang Ltd. 510(k) NO: K213646(Special)
ATTN: Junjie Qian PHONE NO : 86 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 29-MAR-22
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA SMARTPERIO
El.En Electronic Engineering Spa 510(k) NO: K213658(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 11-MAR-22
Calenzano FL 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
Taishan Weibang Medical Equipment 510(k) NO: K213662(Traditional)
ATTN: Shuhui Zhou PHONE NO : 86 137 03060135
No.8, Jiangdong Industrial Park, DSE DECISION MADE: 28-MAR-22
Jiangmen CN 529261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astroglide Sensual Strawberry Personal Lubricant
BioFilm Inc. 510(k) NO: K213671(Traditional)
ATTN: Jennifer Keller PHONE NO : 760 7279030
3225 Executive Ridge SE DECISION MADE: 03-MAR-22
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Pro Implants
Biomet 3i LLC 510(k) NO: K213672(Traditional)
ATTN: Krupal Patel PHONE NO : 561 7766923
4555 Riverside Drive SE DECISION MADE: 28-MAR-22
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Gloves
Lienteh Technology Sdn Bhd 510(k) NO: K213678(Traditional)
ATTN: Irsyad Mazuki PHONE NO : 60 14 5157508
Lot 6483, Jalan Sungai Puloh KU 5,SE DECISION MADE: 22-MAR-22
Klang MY 42100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
NeoCoil, LLC 510(k) NO: K213687(Traditional)
ATTN: Katie Gonzalez PHONE NO : 262 5226124
N27 W23910A Paul Road SE DECISION MADE: 11-MAR-22
Pewaukee WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CareTaker Monitor App
Caretaker Medical, LLC 510(k) NO: K213699(Traditional)
ATTN: Jeff Pompeo PHONE NO : 434 9787000
941 Glenwood Station Ln, Suite 301SE DECISION MADE: 30-MAR-22
Charlottesville VA 22901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Wujiang Tutaike Textiles & Finishi510(k) NO: K213703(Traditional)
ATTN: Zhang Yanwen PHONE NO : 86 151 62512333
No.1599, South 3rd Ring Road, ShenSE DECISION MADE: 04-MAR-22
Suzhou CN 317605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pectus Support Bar System
Biomet Microfixation 510(k) NO: K213712(Traditional)
ATTN: Mark Wladkowski PHONE NO : 904 7414400
1520 Tradeport Drive SE DECISION MADE: 11-MAR-22
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K213721(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 737946870
3 Aminadav St., SE DECISION MADE: 21-MAR-22
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardIQ Suite
GE Medical Systems SCS 510(k) NO: K213725(Traditional)
ATTN: Yonghui Han PHONE NO : 86 10 57083350
283, rue de la Miniere SE DECISION MADE: 11-MAR-22
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clover Glove
Clover Glove Company Limited 510(k) NO: K213729(Traditional)
ATTN: Pongsin Pongwachirint PHONE NO : 66 64 9244991
1999/8 District Sriwara Village, LSE DECISION MADE: 26-MAR-22
Wang Thong Lang TH 10240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Hangzhou Runheng Medical Co., Ltd.510(k) NO: K213736(Traditional)
ATTN: Yaya Lu PHONE NO : 86 182 85158974
Room 201, Shunfeng Building, NO.10SE DECISION MADE: 31-MAR-22
Hangzhou CN 311215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS & EMS DEVICE (Model: FM-B2403A)
Shenzhen Jianfeng Electronic Techn510(k) NO: K213741(Traditional)
ATTN: Feng Wen PHONE NO : 86 755 33858361
902,903 Jialingyu Industrial BuildSE DECISION MADE: 08-MAR-22
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Compression Therapy Device, model: ST-502
Shenzhen Future Electronic Co., Lt510(k) NO: K213745(Traditional)
ATTN: Zhao Qihong PHONE NO : 86 134 10947296
Bldg B. Qiangchengda Industrial PaSE DECISION MADE: 31-MAR-22
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextAR™ TKA Platform My Knee PPS
Medacta International S.A. 510(k) NO: K213751(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 10-MAR-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IV Administration Set
B.Braun Medical Inc. 510(k) NO: K213778(Traditional)
ATTN: Tracy Larish PHONE NO : 610 5965941
901 Marcon Blvd. SE DECISION MADE: 03-MAR-22
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Customize
3D-Side SA 510(k) NO: K213779(Traditional)
ATTN: Laurent Paul PHONE NO : 32 0108 13548
Rue André Dumont 5 SE DECISION MADE: 16-MAR-22
Mont-Saint-Guibert BE 1435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
Mobility Source Medical Technology510(k) NO: K213790(Traditional)
ATTN: Evan Wong PHONE NO : 86 757 88807188
160 Heheng Road, Yanghe Town SE DECISION MADE: 14-MAR-22
Gaoming District, Foshan City CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
Xiantao Zhibo Nonwoven Products Co510(k) NO: K213806(Traditional)
ATTN: Fen Peng PHONE NO : 86 188 72609993
NO.8 in Hefen Industrial Zone, PenSE DECISION MADE: 12-MAR-22
Xiantao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALTEUM - ONE™ Lumbar Plate System
Huvexel Co., Ltd 510(k) NO: K213820(Traditional)
ATTN: Sung Kyu Hur PHONE NO : 82 31 7763690
101-105 Megacenter, SKn TechnoparkSE DECISION MADE: 25-MAR-22
Seongnam-si KR 13207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intera Refill Kit
Intera Oncology, Inc. 510(k) NO: K213823(Special)
ATTN: Michael Gaisford PHONE NO : 617 3314503
65 Williams Street, Suite 200 SE DECISION MADE: 16-MAR-22
Wellesley MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
Smith & Nephew, Inc. 510(k) NO: K213827(Traditional)
ATTN: Stephanie Rincones PHONE NO : 737 2708239
11101 Metric Blvd SE DECISION MADE: 11-MAR-22
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardio Flow Peripheral Guide Wire
Cardio Flow, Inc. 510(k) NO: K213834(Traditional)
ATTN: Michael J. Kallok PHONE NO : 800 2945517
888 East Avenue SE DECISION MADE: 18-MAR-22
Mahtomedi MN 55115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS & EMS Device
Shenzhen Jian feng Electronic Tech510(k) NO: K213835(Traditional)
ATTN: Feng Wen PHONE NO : 86 755 33858361
902,903 Jialingyu Industrial BuildSE DECISION MADE: 03-MAR-22
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc. 510(k) NO: K213836(Traditional)
ATTN: Thomas A Slater PHONE NO : 650 3681000 135
1230 Midas Way, Suite 200 SE DECISION MADE: 11-MAR-22
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Dong Tai City Huayi Gloves Co.,Ltd510(k) NO: K213843(Traditional)
ATTN: Huamei Wang PHONE NO : 86 137 05111918
No.36 Nanzhuang Road, Dongtai HighSE DECISION MADE: 31-MAR-22
Dongtai CN 224249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical nitrile examination gloves (Model: JL001)
Guangdong Jiali Pharmaceutical Co.510(k) NO: K213848(Traditional)
ATTN: Jiali Chen PHONE NO : 86 159 88225228
Dawei, Niugutian Villagers CommittSE DECISION MADE: 25-MAR-22
Jiangmen CN 529143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeOp 2: Neural Informatix System
Alphatec Spine, Inc. 510(k) NO: K213849(Traditional)
ATTN: David Gramse PHONE NO : 760 4946711
1950 Camino Vida Roble SE DECISION MADE: 09-MAR-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile gloves
Guangdong Xingcan Brothers Medical510(k) NO: K213851(Traditional)
ATTN: Suhai Yin PHONE NO : 86 139 24264846
Room B10, 4th Floor, No. 137 (planSE DECISION MADE: 09-MAR-22
Guangzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArthroFree Wireless Surgical Camera System
Lazurite Holdings LLC 510(k) NO: K213860(Traditional)
ATTN: Patrick Polito PHONE NO : 216 3343127
5000 Euclid Avenue, Suite 206 SE DECISION MADE: 23-MAR-22
Cleveland OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmbryoSlide+ ic8 dish
Vitrolife A/S 510(k) NO: K213869(Traditional)
ATTN: Belinda Dueholm PHONE NO : 45 20 763707
Jens Juuls Vej 20 SE DECISION MADE: 11-MAR-22
Viby J DK 8260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAL-1A Plus Blood Glucose Monitoring System
Apex BioTechnology Corp. 510(k) NO: K213887(Special)
ATTN: Lisa Liu PHONE NO : 011 886 35641952
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 29-MAR-22
Hsinchu CN 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DWFritz ASM2000
DWFritz Automation, Inc. 510(k) NO: K213894(Traditional)
ATTN: Curtis Smith PHONE NO : 503 8857030
9600 SW Boeckman Drive SE DECISION MADE: 14-MAR-22
Wilsonville OR 97070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Trek Powered Bone Biopsy System
Bard Peripheral Vascular 510(k) NO: K213896(Traditional)
ATTN: Courtney Willson PHONE NO : 602 8305579
1625 W. 3rd Street SE DECISION MADE: 30-MAR-22
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CareGUARD Sterilization Wrap
Care Essentials Pty Ltd 510(k) NO: K213907(Traditional)
ATTN: Abhay Sinha PHONE NO : 61 3 52771455
103 Mornington Street SE DECISION MADE: 14-MAR-22
North Geelong AU 3215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
Changzhou Universal Medical Equipm510(k) NO: K213910(Traditional)
ATTN: Cai Jin Fu PHONE NO : 86 136 55000068
No. 6, Xinxi Road, Xinbei DistrictSE DECISION MADE: 10-MAR-22
Changzhou CN 213000 510(k) STATEMENT
DEVICE: A-dec 300, A-dec 500
A-dec, Inc. 510(k) NO: K213932(Traditional)
ATTN: Raquel Peregrino de Brito PHONE NO : 503 5389471 2255
2601 Crestview Drive SE DECISION MADE: 02-MAR-22
Newberg OR 97132 510(k) STATEMENT
DEVICE: OxyMinder
Bio-Med Devices, Inc. 510(k) NO: K213948(Traditional)
ATTN: Ken K Close PHONE NO : 203 4580202 217
61 Soundview Rd SE DECISION MADE: 17-MAR-22
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Demetra Dermatoscope BDEM-01
Barco NV 510(k) NO: K213957(Special)
ATTN: Imke Storm PHONE NO : 32 470 189293
President Kennedypark 35 SE DECISION MADE: 11-MAR-22
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeautiBond Xtreme
Shofu Dental Corporation 510(k) NO: K213965(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277 202
1225 Stone Drive SE DECISION MADE: 18-MAR-22
San Marcos CA 92078 510(k) STATEMENT
DEVICE: Peridot Spinal Interbody System
GBS Commonwealth Co., Ltd. 510(k) NO: K213980(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 15-MAR-22
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Block
Shandong Huge Dental Material Corp510(k) NO: K213994(Traditional)
ATTN: Maggie Zheng PHONE NO : 086 633 2277268
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 04-MAR-22
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15L Cycler Drainage Bag
Baxter Healthcare Corporation 510(k) NO: K214016(Traditional)
ATTN: Maninee Patel PHONE NO : 224 9483656
One Baxter Parkway SE DECISION MADE: 18-MAR-22
Deerfield IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ P10, LOGIQ P9, LOGIQ P8
GE Medical Systems Ultrasound and 510(k) NO: K214039(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
LLC 9900 Innovation Dr. SE DECISION MADE: 22-MAR-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K214043(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 14-MAR-22
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EL CAPITAN Anterior Lumbar Interbody Fusion System
Astura Medical 510(k) NO: K214047(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530 503
4949 W Royal Ln. SE DECISION MADE: 30-MAR-22
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATIM 6000B Vacuum Autoclave
SciCan Ltd. 510(k) NO: K214057(Abbreviated)
ATTN: Teresa Boyce PHONE NO : 416 4462783
1440 Don Mills Road SE DECISION MADE: 31-MAR-22
Toronto CA M3B 3P9 510(k) STATEMENT
DEVICE: Hexa-Temp
SPIDENT CO., LTD. 510(k) NO: K214071(Traditional)
ATTN: J.M. Ahn PHONE NO : 82 10 37350888
203 & 312, Korea Industrial CompleSE DECISION MADE: 10-MAR-22
Gojan-Dong, Namdong-Gu KR 405-821510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Hubei Medlink Healthcare Co., Ltd 510(k) NO: K214087(Traditional)
ATTN: Sophie Liu PHONE NO : 86 27 84621898
36F, Tower1, New World InternationSE DECISION MADE: 08-MAR-22
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Image Plate Scanner, Model DFC-4T-SMART
Hefei DentaFilm Medical Equipment 510(k) NO: K214091(Traditional)
ATTN: Ming Chang Qiu PHONE NO : 86 551 63528008
No. 98 Tangkou Road, Economic and SE DECISION MADE: 02-MAR-22
Hefei CN 230601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSP Bolus
3D Systems 510(k) NO: K214093(Traditional)
ATTN: Benjamin Johnson PHONE NO : 720 6431001
5381 S Alkire Circle SE DECISION MADE: 30-MAR-22
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Project E Beauty LED Light Therapy Mask (Model: PE730)
Duplex International Trading Limit510(k) NO: K214101(Traditional)
ATTN: Patrick Lee PHONE NO : 852 31 063608
B1, 10/F, Block 2, Golden Dragon ISE DECISION MADE: 23-MAR-22
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shani Darden LED light therapy mask
Harpar Grace International 510(k) NO: K214103(Traditional)
ATTN: Alana Marie Chalmers PHONE NO : 44 020 38686242
Unit 4 Imperial Court, Magellan ClSE DECISION MADE: 22-MAR-22
Andover GB SP10 5NT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hand-held IPL device(JOVS Graphene Hair Removal Device)
Shenzhen Qianyu Technology Co., Lt510(k) NO: K214113(Traditional)
ATTN: Kunming Lin PHONE NO : 86 158 13806593
Room 1002, Building A2, KeXing SciSE DECISION MADE: 28-MAR-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: angioLOCK Polymer Ligating Clip
A2 Medical Systems, LLC 510(k) NO: K220006(Traditional)
ATTN: Robert Hall PHONE NO : 919 5382325
6387 Technology Ave. SE DECISION MADE: 02-MAR-22
Kalamazoo MI 49009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Elastography; MZEK-001A
Canon Medical Systems Corporation 510(k) NO: K220018(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 03-MAR-22
Otawara-Shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARx® Spinal System
Life Spine, Inc. 510(k) NO: K220025(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 31-MAR-22
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC 510(k) NO: K220049(Traditional)
ATTN: Andy Rynearson PHONE NO : 321 3162601
6052 Turkey Lake Road SE DECISION MADE: 14-MAR-22
Orlando FL 32819 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K220051(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 04-MAR-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4K UHD LCD Monitor OEV321UH
Olympus Medical Systems Corp. 510(k) NO: K220069(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 09-MAR-22
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine 3DP Lumbar Interbody System
Genesys Spine 510(k) NO: K220096(Special)
ATTN: Chloe Lance PHONE NO : 512 3817089
1250 South Capital of Texas HighwaSE DECISION MADE: 09-MAR-22
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems Inc. 510(k) NO: K220109(Special)
ATTN: Nikita Basandra PHONE NO : 651 2598206
1225 Old Highway 8 NW SE DECISION MADE: 01-MAR-22
Saint Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilization Wraps
Weihai Hongyu Nonwoven Fabric Prod510(k) NO: K220133(Traditional)
ATTN: Bin Dong PHONE NO : 86 156 62383633
No.567, Gushan Road, Area of EconoSE DECISION MADE: 10-MAR-22
Weihai CN 264207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Needle Stimulator (Model: RJNS6-1)
Bozhou Rongjian Medical Appliance 510(k) NO: K220153(Traditional)
ATTN: Wu Zhifang PHONE NO : 86 558 7662968
Jianghuai Supply Base, Zhongkai GrSE DECISION MADE: 18-MAR-22
Bozhou CN 233500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PediGuard Threaded
Spine Guard S.A. 510(k) NO: K220160(Traditional)
ATTN: Stephane Bette PHONE NO : 33 07 60082737
10 Cours Louis Lumiere SE DECISION MADE: 31-MAR-22
Vincennes FR 94300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Total Immunoglobulin E (IgE)
Beckman Coulter, Inc. 510(k) NO: K220178(Traditional)
ATTN: Veronica Colinayo PHONE NO : 714 9616515
250 S. Kraemer Boulevard, Mail StoSE DECISION MADE: 23-MAR-22
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthFix Intraosseous Fixation System
Nextremity Solutions, Inc. 510(k) NO: K220181(Traditional)
ATTN: Elise Fox PHONE NO : 574 376206
1195 Polk Drive SE DECISION MADE: 22-MAR-22
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aggeris™-C
Clariance 510(k) NO: K220182(Traditional)
ATTN: Mélody La Porte PHONE NO : 33 2 21161215
18, rue Robespierre SE DECISION MADE: 30-MAR-22
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask (Model: JM92, JM92B)
Guangdong Jia Mei Biological techn510(k) NO: K220187(Traditional)
ATTN: Jiali Chen PHONE NO : 86 159 88225228
3/F, Block 1, No.356 Qinglan Road,SE DECISION MADE: 25-MAR-22
Jiangmen CN 529040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steth IO Spot
StratoScientific 510(k) NO: K220196(Third Party - Traditional)
ATTN: Mahesh Mulumudi PHONE NO : 1 425 8764310
19125 North Creek Pkwy #120 SE DECISION MADE: 24-MAR-22
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AFFINITY Proximal Tibia System
Techfit Digital Surgery INC. 510(k) NO: K220199(Traditional)
ATTN: Leidy Johanna Toro-Gonzalez PHONE NO : 605 5170321
1511 Aviation Center Pkwy, Suite 2SE DECISION MADE: 21-MAR-22
Daytona Beach FL 32114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uterine ElevatOR PRO with OccludOR Balloon
The O R Company Pty Ltd 510(k) NO: K220202(Traditional)
ATTN: Nicole Conway PHONE NO : 61 3 94135555
1/32 Silkwood Rise SE DECISION MADE: 31-MAR-22
Carrum Downs AU 3201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility Scooter
Zhejiang Innuovo Rehabilitation De510(k) NO: K220206(Traditional)
ATTN: Leo Zheng PHONE NO : 86 183 58936043
No.196 Industry Road, Hengdian MovSE DECISION MADE: 24-MAR-22
Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility Scooter, Model W3468
Zhejiang Innuovo Rehabilitation De510(k) NO: K220207(Traditional)
ATTN: Leo Zheng PHONE NO : 86 183 58936043
No.196 Industry Road, Hengdian MovSE DECISION MADE: 24-MAR-22
Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empulse R90
Sunrise Medical (US) LLC 510(k) NO: K220213(Traditional)
ATTN: Devin McElroy PHONE NO : 1 559 2942374
2842 N Business Park Ave. SE DECISION MADE: 30-MAR-22
Fresno CA 93727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
KSG MEDICARE Sdn. Bhd. 510(k) NO: K220215(Traditional)
ATTN: Jennifer Yeo PHONE NO : 603 77331388
PTD 16063, Kawasan Perindustrian SE DECISION MADE: 26-MAR-22
Tangkak MY 84900 510(k) STATEMENT
DEVICE: Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
Shandong Blue Sail Health Technolo510(k) NO: K220228(Traditional)
ATTN: Shi Haifeng PHONE NO : 0086 533 7871217
No. 1888 Langgao Road, Langshan AdSE DECISION MADE: 18-MAR-22
Weifang CN 262600 510(k) STATEMENT
DEVICE: Powder Free Nitrile Examination Gloves, Orange
Shanxi Hongjin Plastic Technology 510(k) NO: K220229(Traditional)
ATTN: Wu Zhigang PHONE NO : 86 311 66179668
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 26-MAR-22
Linfen CN 042300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Co-Polymer Powder-free Examination Gloves, Black
Grand Work Plastic Products Co., L510(k) NO: K220240(Traditional)
ATTN: Wu Yuli PHONE NO : 86 311 66766067
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 31-MAR-22
Shijiazhuang CN 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K220242(Traditional)
ATTN: Jiang Xiaoyong PHONE NO : 86 755 81886238
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 25-MAR-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guidewire Locking Device
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K220247(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 29-MAR-22
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL INTELLIGENCE CORI
Blue Belt Technologies, Inc. 510(k) NO: K220255(Traditional)
ATTN: Corrine Herlinger PHONE NO : 412 6833844 4128
2905 Northwest Blvd., Ste. 40 SE DECISION MADE: 29-MAR-22
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hercules Syndesmosis Implant System
In2Bones USA, LLC 510(k) NO: K220260(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 31-MAR-22
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE Anterior Cervical Plate System
Evolution Spine 510(k) NO: K220275(Traditional)
ATTN: Todd Wallenstein PHONE NO : 571 5947409
2300 N. Haskell Ave SE DECISION MADE: 18-MAR-22
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXT SPINE NAVIGATION System
Nexxt Spine LLC 510(k) NO: K220291(Traditional)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 31-MAR-22
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
Orthocon, Inc. 510(k) NO: K220315(Traditional)
ATTN: Aniq Darr PHONE NO : 914 3572600
1 Bridge Street, Suite 121 SE DECISION MADE: 11-MAR-22
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuFit Lateral 2-Hole Plate
Precision Spine, Inc. 510(k) NO: K220324(Traditional)
ATTN: Michael Dawson PHONE NO : 601 4204244
2050 Executive Drive SE DECISION MADE: 16-MAR-22
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: geko W-3
Firstkind Limited 510(k) NO: K220327(Special)
ATTN: Neil Buckley PHONE NO : 44 845 2222921
Hawk House, Peregrine Business ParSE DECISION MADE: 04-MAR-22
High Wycombe GB HP13 7DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amplatzer Steerable Delivery Sheath
Abbott Medical 510(k) NO: K220340(Special)
ATTN: Emily Jallen PHONE NO : 612 41184341
5050 Nathan Lane N SE DECISION MADE: 09-MAR-22
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
Niujian Technology Co., Ltd 510(k) NO: K220353(Traditional)
ATTN: Alan Chow PHONE NO : 86 182 10518920
Room 401, Building 1, Anfangcheng,SE DECISION MADE: 31-MAR-22
Shaoxing CN 312030 510(k) STATEMENT
DEVICE: Disposable Medical Synthetic Nitrile Examination Gloves
Niujian Technology Co., Ltd 510(k) NO: K220354(Traditional)
ATTN: Alan Chow PHONE NO : 86 182 10518920
Room 401, Building 1, Anfangcheng,SE DECISION MADE: 24-MAR-22
Shaoxing CN 312030 510(k) STATEMENT
DEVICE: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
STERIS Corporation 510(k) NO: K220361(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 10-MAR-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LE-12CH
CAF Medical Solutions Inc. 510(k) NO: K220362(Traditional)
ATTN: Oscar Arriaga Yamin PHONE NO : 1 713 6147049
17539 Roberts Road SE DECISION MADE: 25-MAR-22
Hockley TX 77477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
Medos International SARL 510(k) NO: K220374(Special)
ATTN: Megan Smith PHONE NO : 978 5388797
Chemin-Blanc 38 SE DECISION MADE: 08-MAR-22
LeLocle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acetabular Dome Hole Plug
Howmedica Osteonics Corp., dba Str510(k) NO: K220376(Special)
ATTN: Lin Song PHONE NO : 201 8316617
325 Corporate Drive SE DECISION MADE: 09-MAR-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
Medynus Inc. 510(k) NO: K220379(Traditional)
ATTN: David Shin PHONE NO : 949 9320847
18 Technology Dr. Ste 109 SE DECISION MADE: 03-MAR-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoGator Endoscopy Irrigation Tubing
STERIS Corporation 510(k) NO: K220395(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5960 Heisley Road SE DECISION MADE: 11-MAR-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental sensors NanoPix1, NanoPix2
iRay Technology Taicang Ltd. 510(k) NO: K220422(Special)
ATTN: Guo Wu PHONE NO : 86 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 11-MAR-22
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida, MAGNETOM Sola
Siemens Medical Solutions USA, Inc510(k) NO: K220425(Traditional)
ATTN: Alina Goodman PHONE NO : 224 5261404
40 Liberty Boulevard SE DECISION MADE: 11-MAR-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiber Dust PRO
Quanta System Spa 510(k) NO: K220426(Special)
ATTN: Dario Bandiera PHONE NO : 39 0331 376797
Via Acquedotto, 109 SE DECISION MADE: 16-MAR-22
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Applications
Siemens Medical Solutions USA Inc.510(k) NO: K220450(Special)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 07-MAR-22
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlareHawk Interbody Fusion System
Integrity Implants Inc. 510(k) NO: K220453(Special)
ATTN: Anne Mulvihill PHONE NO : 561 5293861
354 Hiatt Drive SE DECISION MADE: 24-MAR-22
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELERITY 20 HP Challenge Pack
STERIS 510(k) NO: K220473(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd. SE DECISION MADE: 18-MAR-22
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPAL exchange G hip spacer
Heraeus Medical GmbH 510(k) NO: K220492(Special)
ATTN: Heike Gustke PHONE NO : 49 6181 352942
Philipp-Reis-Str. 8/13 SE DECISION MADE: 23-MAR-22
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pounce Thrombectomy System
Surmodics Inc. 510(k) NO: K220501(Special)
ATTN: Holly Ramirez PHONE NO : 763 5007545
7905 Golden Triangle Drive Suite 1SE DECISION MADE: 23-MAR-22
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkinPen Precision System
Crown Aesthetics 510(k) NO: K220506(Special)
ATTN: Marie Fogartie PHONE NO : 423 6302296
5005 Lyndon B. Johnson Frwy., SuitSE DECISION MADE: 07-MAR-22
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE IM Fibula Implant
Medline Industries, LP 510(k) NO: K220511(Special)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 22-MAR-22
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia Zerona Z-Bed
Erchonia Corporation 510(k) NO: K220519(Third Party - Traditional)
ATTN: Travis Sammons PHONE NO : 888 2420571
650 Atlantis Road SE DECISION MADE: 24-MAR-22
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Merits P335 Powered Wheelchair
Merits Health Products Co., LTD. 510(k) NO: K220529(Third Party - Abbreviated)
ATTN: Martin Tseng PHONE NO : 886 4 23594985 200
No. 18, Jingke Rd., Nantun Dist. SE DECISION MADE: 18-MAR-22
Taichung TW 40852 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BD Cathena Safety IV Catheter
Becton Dickinson Infusion Therapy 510(k) NO: K220584(Special)
ATTN: Paul Holman PHONE NO : 801 5225132
9450 South State Street SE DECISION MADE: 31-MAR-22
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artix Thrombectomy Device
Inari Medical 510(k) NO: K220600(Special)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon, Suite 100 SE DECISION MADE: 25-MAR-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIVISIO Device
Ecential Robotics 510(k) NO: K220627(Special)
ATTN: Mathilde Saulpic PHONE NO : 0033 4 58003586
Zone Mayencin II, Parc Equation - SE DECISION MADE: 18-MAR-22
Gieres FR 38610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emerge Monorail PTCA Dilatation Catheter
Boston Scientific 510(k) NO: K220629(Special)
ATTN: Aoife O'Flaherty PHONE NO : 35 391 517299
Ballybrit Business Park, BallybritSE DECISION MADE: 24-MAR-22
Galway IE H91Y868 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3 Ply Medical Grade Single Use Procedural Disposable Face Mask
KDI Med Supply 510(k) NO: K220637(Third Party - Traditional)
ATTN: Yolanda Davis PHONE NO : 419 3070305
206 Lynn St SE DECISION MADE: 25-MAR-22
Fremont OH 43420 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc 510(k) NO: K220655(Special)
ATTN: Robert Jaramillo PHONE NO : 925 8192257
110 Pioneer Way, Ste 1 SE DECISION MADE: 24-MAR-22
Mountain View CA 94041-1519 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TargetCool
RecensMedical Inc. 510(k) NO: K220674(Special)
ATTN: Yeonui Lee PHONE NO : 82 31 80433064
908, SK V1 center, 830 DongtansunhSE DECISION MADE: 31-MAR-22
Hwaseong-si KR 18468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APX-24 Portable X-ray System
Aspenstate INC 510(k) NO: K220678(Traditional)
ATTN: Albert Kim PHONE NO : 1 214 2570113
801 North Jupiter Rd, Suite 200 SE DECISION MADE: 31-MAR-22
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K Clear
K Line Europe GmbH 510(k) NO: K220726(Third Party - Traditional)
ATTN: Sherif Kandil PHONE NO : 49 211 93896976
Niederrheinstraße 16 SE DECISION MADE: 16-MAR-22
Dusseldorf DE 40474 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 288
TOTAL WITH SUMMARIES 273
TOTAL WITH STATEMENTS 15
