510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2022
DEVICE: CardioChek Plus Test System; CardioChek Plus Home Test System
Polymer Technology Systems, Inc. d510(k) NO: K193406(Traditional)
ATTN: Margo Enright PHONE NO : 317 8705610 1012
4600 Anson Boulevard SE DECISION MADE: 26-FEB-22
Whitestown IN 46075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEC-LED
MICRO-NX Co., Ltd. 510(k) NO: K201191(Traditional)
ATTN: Jong-Kun Kee PHONE NO : 82 53 6501000
22 Maeyeo-ro 1gil, Dong-gu SE DECISION MADE: 07-FEB-22
Daegu KR 41059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATtrol BD MAX Vaginal Panel External Controls
Zeptometrix 510(k) NO: K201403(Traditional)
ATTN: Shawn Smith PHONE NO : 716 8820920
878 Main Street SE DECISION MADE: 02-FEB-22
Buffalo NY 14202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Traufix osteosynthesis, osteotomy, and arthrodesis devices
Fixier, S.A. de C.V. 510(k) NO: K201510(Traditional)
ATTN: Vianey Mariana Perez Suarez PHONE NO : 477 7180018
Calle Joaquín Pardavé No. 223 ColoSE DECISION MADE: 18-FEB-22
Leon MX C.P. 37170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NervAlign Nerve Cuff
Renerve Ltd 510(k) NO: K202234(Traditional)
ATTN: David Rhodes PHONE NO :
Suite 3, 21 Vale Street SE DECISION MADE: 10-FEB-22
North Melbourne AU 3051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acetaminophen
Sekisui Diagnostics P.E.I. INC. 510(k) NO: K202644(Traditional)
ATTN: Penny White PHONE NO : 902 6280934
70 Watts Avenue SE DECISION MADE: 18-FEB-22
Charlottetown CA C1E 2B9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Action Trackchair Hawk
Action Manufacturing Inc. 510(k) NO: K202728(Traditional)
ATTN: Alan Macht PHONE NO : 507 5325940
1105 Lake Road SE DECISION MADE: 10-FEB-22
Marshall MN 56258 510(k) STATEMENT
DEVICE: Bodygard SFS Surgical Gown Level 3
Feliks Plastik Laminasyon Ve Ambal510(k) NO: K202845(Traditional)
ATTN: Ali Serdar Serteser PHONE NO : 90 22 22362353
Eskisehir Industrial Zone 26 th StSE DECISION MADE: 24-FEB-22
Eskisehir TR 26100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micro Catheter
Shanghai Heartcare Medical Technol510(k) NO: K202926(Traditional)
ATTN: Zongyu Xue PHONE NO : 86 18 621683501
590 Ruiqing Rd, Building 4, Suite SE DECISION MADE: 10-FEB-22
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity Acute Care System (IACS) Monitoring System
Draeger Medical Systems, Inc. 510(k) NO: K203088(Traditional)
ATTN: Deborah Herrington PHONE NO : 978 3798002
6 Tech Dr. SE DECISION MADE: 01-FEB-22
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo SedLine Sedation Monitor and Accessories
Masimo Corporation 510(k) NO: K203113(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 3964041
52 Discovery SE DECISION MADE: 25-FEB-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cool-tip RF Ablation System E Series
Covidien LLC 510(k) NO: K203150(Traditional)
ATTN: Liron Bar Yaakov PHONE NO : 303 5816668
5920 Longbow Drive SE DECISION MADE: 25-FEB-22
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Tandem Diabetes Care, Inc. 510(k) NO: K203234(Traditional)
ATTN: Ashley Reynolds PHONE NO : 858 3666900
11075 Roselle Street SE DECISION MADE: 15-FEB-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaScrew Extension
Medacta International SA 510(k) NO: K203335(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 03-FEB-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PainTB, PainTJ
Ptech Co., Ltd. 510(k) NO: K203337(Traditional)
ATTN: Yosung Choi PHONE NO : 82 10 40517344
35, Wondogok-gil, Poseung-eup SE DECISION MADE: 11-FEB-22
Pyeongtaek-si KR 13449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Okamoto 002 Lubricated Polyurethane Male Condom
Okamoto U.S.A. Inc. 510(k) NO: K203541(Traditional)
ATTN: Yu Tadano PHONE NO : 203 3780003 301
18 King Street SE DECISION MADE: 25-FEB-22
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoArmor™ + Surgical Gown
Boston Scientific Corporation 510(k) NO: K203548(Traditional)
ATTN: Laura Kuroski PHONE NO : 508 6834406
100 Boston Scientific Way SE DECISION MADE: 21-FEB-22
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoSerter-PL
CorneaGen, Inc 510(k) NO: K203586(Traditional)
ATTN: Tom Miller PHONE NO : 206 2763864 1058
101 N. Chestnut Street, Suite 303 SE DECISION MADE: 02-FEB-22
Winston Salem NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RithmID-SD Steerable Diagnostic Electrophysiology Catheter
Synaptic Medical Corporation 510(k) NO: K203793(Traditional)
ATTN: Charles Yang PHONE NO : 760 6088388
1817 Aston Ave Suite 101 SE DECISION MADE: 14-FEB-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GPC Intraheal Intramedullary Nailing System
GPC Medical Limited 510(k) NO: K203811(Traditional)
ATTN: Vikas Narang PHONE NO : 91 11 43222600
GPC Square, M-Block, DDA LSC, VikaSE DECISION MADE: 10-FEB-22
New Delhi IN 110018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
3M Health Care Business Group 510(k) NO: K210135(Traditional)
ATTN: Margaret Marsh PHONE NO : 210 2556481
3M Centre, Cain Road SE DECISION MADE: 24-FEB-22
Berkshire, Bracknell Forest GB RG510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titan Condoms
Titan Condoms LLC 510(k) NO: K210208(Traditional)
ATTN: Neville Muringayi PHONE NO : 951 7466130
1950 Elkhorn Ct. Unit. 210 SE DECISION MADE: 17-FEB-22
San Mateo CA 94403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Auto-Disable Syringes with/without Needle for Single Use
Zhejiang Kangkang Medical-Devices 510(k) NO: K210229(Traditional)
ATTN: Chun Guo PHONE NO : 1358 6180908
Longwang Industrial District, ChumSE DECISION MADE: 15-FEB-22
Yuhuan CN 317605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noris Medical Dental Implants System
Noris Medical Ltd 510(k) NO: K210356(Traditional)
ATTN: Simha Sibony PHONE NO : 972 73 7964477
8 Hataasia SE DECISION MADE: 04-FEB-22
Nesher IL 3688808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Morpheus
S4S UK Ltd. 510(k) NO: K210636(Traditional)
ATTN: Matthew Everatt PHONE NO : 44 114 2500176
151 Rutland Road SE DECISION MADE: 15-FEB-22
Sheffield GB S3 9PT 510(k) STATEMENT
DEVICE: HotDog Warming Mattress + Return Electrode
Augustine Temperature Management L510(k) NO: K210727(Abbreviated)
ATTN: Temi Ogunse PHONE NO : 952 4653539
7656 West 78th Street SE DECISION MADE: 01-FEB-22
Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Healing Abutment, Cover Screw
MegaGen Implant Co., Ltd. 510(k) NO: K210826(Traditional)
ATTN: You Jung Kim PHONE NO : 82 53 2222828
45, Secheon-ro, 7-gil SE DECISION MADE: 03-FEB-22
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOCLEAN CLEANsert Ultrasonic Insert
TTBIO CORP. 510(k) NO: K210832(Traditional)
ATTN: Sheng-Chieh Su PHONE NO : 886 423595958
2F, No.7, 6th Road, Industry Park SE DECISION MADE: 02-FEB-22
Taichung TW 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Pen Needle
Sandstone Medical (Suzhou) Inc. 510(k) NO: K210864(Traditional)
ATTN: Juanjuan Sun PHONE NO : 86 512 65799368
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 17-FEB-22
Suzhou CN 215153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump
Shantou Huihengqi Electronic Techn510(k) NO: K211024(Traditional)
ATTN: Gensong Yang PHONE NO : 86 0754 88893348
501, 5/F, Block C, 14A Industrial SE DECISION MADE: 11-FEB-22
Shantou CN 515000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LoFric Elle
Dentsply Sirona 510(k) NO: K211212(Traditional)
ATTN: Rebecca Sporer PHONE NO : 717 4954286
221 W Philadelphia Street, Suite 6SE DECISION MADE: 17-FEB-22
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rosso
Quanta System SpA 510(k) NO: K211228(Traditional)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 676797
Via Acquedotto 109 SE DECISION MADE: 02-FEB-22
Samarate IT Varese 510(k) STATEMENT
DEVICE: ArtUs
Telemed 510(k) NO: K211248(Traditional)
ATTN: Yury Sokolov PHONE NO : 370 5 2106272
Highway Business Centre Savanoriu SE DECISION MADE: 11-FEB-22
Vilnius LT LT-03154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPRI Corpectomy Cage System
K2M, Inc. 510(k) NO: K211320(Traditional)
ATTN: Renee Norby PHONE NO : 201 7254954
600 Hope Parkway SE SE DECISION MADE: 24-FEB-22
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
CathRxLtd 510(k) NO: K211327(Traditional)
ATTN: Lucy Huang PHONE NO : 61 2 78041846
Unit 8, 2-8 South St SE DECISION MADE: 10-FEB-22
Rydalmere AU 2116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K211400(Traditional)
ATTN: Haiying Zhao PHONE NO : 86 10 88794631
No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 11-FEB-22
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F3D-C2 Cervical Stand-Alone System
CoreLink, LLC 510(k) NO: K211417(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Blvd. SE DECISION MADE: 04-FEB-22
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uLab Systems Dental Aligner Kit
uLab Systems, Inc. 510(k) NO: K211510(Traditional)
ATTN: Amir Albolfathi PHONE NO : 650 8041397
1820 Gateway Drive, Suite 300 SE DECISION MADE: 24-FEB-22
San Mateo CA 94404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathBuilder Steerable Introducer
Shanghai MicroPort EP MedTech Co.,510(k) NO: K211530(Traditional)
ATTN: Tian Xia PHONE NO : 86 21 38954600 3613
Building 23&28, Lane 588, TianxionSE DECISION MADE: 08-FEB-22
Shanghai CN 201318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zeolite Hemostatic Gauze
Hangzhou Zeo-Innov Life Technology510(k) NO: K211570(Traditional)
ATTN: Lijuan Zhao PHONE NO : 86 571 86651470
R101, Building 2, No.291 Fucheng RSE DECISION MADE: 10-FEB-22
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
Pegavision Corporation 510(k) NO: K211603(Traditional)
ATTN: Estela Lin PHONE NO : 886 3329 8808
2F-1, No. 5 Shing Yeh St SE DECISION MADE: 02-FEB-22
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fogarty Occlusion Catheter
Edwards Lifesciences, LLC 510(k) NO: K211610(Traditional)
ATTN: Anisha Butala PHONE NO : 949 2501004
One Edwards Way SE DECISION MADE: 14-FEB-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrascanner
Infrascan, Inc. 510(k) NO: K211617(Traditional)
ATTN: Baruch Ben Dor PHONE NO : 215 3876784
3508 Market Street SE DECISION MADE: 09-FEB-22
Philadelphia PA 19104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epione
Quantum Surgical SAS 510(k) NO: K211645(Traditional)
ATTN: Lagacherie Elise PHONE NO : 33 448 194050
ZAC Eureka 1000 rue du Mas de VercSE DECISION MADE: 24-FEB-22
Montpellier FR 34000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFit enteral syringes (NUTRIFIT)
Pentaferte Italia S.R.L. 510(k) NO: K211661(Traditional)
ATTN: Rosa Di Gioia PHONE NO :
Viale Piane Nocella, 23 SE DECISION MADE: 28-FEB-22
Campli IT i-64012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xtractor device
Xcardia Innovation Ltd. 510(k) NO: K211679(Traditional)
ATTN: Benny Rousso PHONE NO : 972 544 345653
1 Hamada Street SE DECISION MADE: 17-FEB-22
Rehovot IL 7670301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible Video-Choledo-Cysto-Ureteroscope System
Shanghai SeeGen Photoelectric Tech510(k) NO: K211686(Traditional)
ATTN: Yvonne Fei PHONE NO : 0086 13 701701046
3 Floor, Building No.1, 4299 JinDuSE DECISION MADE: 22-FEB-22
Shanghai CN 201108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Guide® Surgical Navigation System
X-Nav Technologies, LLC 510(k) NO: K211701(Traditional)
ATTN: Kimberly Chan PHONE NO : 267 4360414
1555 Bustard Road, Suite 75 SE DECISION MADE: 01-FEB-22
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniTom Elite
NeuroLogica Corporation, a subsidi510(k) NO: K211711(Traditional)
ATTN: Ninad Gujar PHONE NO : 978 5648632
Co., Ltd 14 Electronics Avenue SE DECISION MADE: 25-FEB-22
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
Orthofix US LLC 510(k) NO: K211712(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 11-FEB-22
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
Canadian Pioneer Medical Technolog510(k) NO: K211722(Traditional)
ATTN: Rashid Reza Mir Reza Mir PHONE NO : 1 437 7727788
Unit 2 -210 Drumlin Circle, ConcorSE DECISION MADE: 25-FEB-22
Vaughan CA L4K 3E3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pocket Ultrasound System
GuangDong Youkey Medical Co., Ltd.510(k) NO: K211746(Traditional)
ATTN: Hu Zeyi PHONE NO : 086 0757 86258600
Unit 601, Block B, Building 1, B1 SE DECISION MADE: 18-FEB-22
Foshan CN 528203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cleaner Plus Thrombectomy System
Argon Medical Devices, Inc. 510(k) NO: K211798(Traditional)
ATTN: Ana Jimenez-Hughes PHONE NO : 903 6764276
1445 Flat Creek Road SE DECISION MADE: 24-FEB-22
Athens TX 75751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifePath Remote Patient Monitoring Platform
Elastic Care Incorporated 510(k) NO: K211822(Third Party - Traditional)
ATTN: Ashok Kalle PHONE NO : 416 7045141
95 Apple Creek Blvd. SE DECISION MADE: 03-FEB-22
Markham CA L3R 1C7 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ion Facet Screw System
SurGenTec, LLC 510(k) NO: K211855(Traditional)
ATTN: Andrew Shoup PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 25-FEB-22
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimRouter Neuromodulation System
Bioness Inc. 510(k) NO: K211965(Traditional)
ATTN: Sageev George PHONE NO : 661 3889303
25103 Rye Canyon Loop SE DECISION MADE: 23-FEB-22
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Powder Free Examination Glove
Top Glove Vietnam Company Limited 510(k) NO: K212011(Traditional)
ATTN: Natrisya Nur Binti Abdul RahPHONE NO : 60 333 623043
Lot A_8B_CN, Street N3, Bau Bang ISE DECISION MADE: 14-FEB-22
Bau Bang VN 75000 510(k) STATEMENT
DEVICE: TeesuVac Breast Biopsy Device Mark 1
TeesuVac ApS 510(k) NO: K212079(Traditional)
ATTN: John Hvidkjaer PHONE NO : 45 61 558399
Agern Alle 3 SE DECISION MADE: 02-FEB-22
Hoersholm DK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Vascular Solutions LLC 510(k) NO: K212167(Traditional)
ATTN: Beka Vite PHONE NO : 763 7622601
6464 Sycamore Court N SE DECISION MADE: 09-FEB-22
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable Breast Pump (Model S12)
Shenzhen TPH Technology Co., Ltd. 510(k) NO: K212180(Traditional)
ATTN: Peter Chen PHONE NO : 86 755 82703212
Bulan Road, Nanwan Community, LongSE DECISION MADE: 11-FEB-22
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
Vascular Solutions LLC 510(k) NO: K212211(Traditional)
ATTN: Rebecca Astrup PHONE NO : 763 7622601
6464 Sycamore Court N SE DECISION MADE: 09-FEB-22
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multitom Rax with True2scale Body Scan Option
Siemens Medical Solutions 510(k) NO: K212212(Traditional)
ATTN: Denise Adams PHONE NO : 610 9442184
40 Liberty Boulevard SE DECISION MADE: 18-FEB-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Cepheid 510(k) NO: K212213(Traditional)
ATTN: Suzette Chance PHONE NO : 262 6231775
904 Caribbean Drive SE DECISION MADE: 09-FEB-22
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: smart-sync
northh medical GmbH 510(k) NO: K212271(Traditional)
ATTN: Kai-Kristoph Fehrs PHONE NO : 49 176 24812117
Roentgenstrasse 24 SE DECISION MADE: 04-FEB-22
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Mericonn Technology Co., 510(k) NO: K212300(Traditional)
ATTN: Jiang Chuanyuan PHONE NO : 0086 139 28416535
Room 20203, Building 6, DonglongxiSE DECISION MADE: 25-FEB-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heartland Health Surgical Mask
Heartland Health Products 510(k) NO: K212366(Abbreviated)
ATTN: Frank Fischer PHONE NO : 513 8701611
5389 East Provident Dr SE DECISION MADE: 19-FEB-22
Cincinnati OH 45246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arsenal Ankle Plating System
Trilliant Surgical 510(k) NO: K212378(Traditional)
ATTN: Sofia Middleton PHONE NO : 318 3939657
727 North Shepherd Drive, Suite 10SE DECISION MADE: 23-FEB-22
Houston TX 77007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
Ethicon, Inc. 510(k) NO: K212380(Traditional)
ATTN: Marife Sevek PHONE NO : 908 8086602
1000 Route 202 SE DECISION MADE: 22-FEB-22
Raritan NJ 08869 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu® aScope™ Gastro, Ambu® aBox™2
Ambu A/S 510(k) NO: K212382(Traditional)
ATTN: Mette Anderson PHONE NO : 45 7225 2106
Baltorpbakken 13 SE DECISION MADE: 03-FEB-22
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Shenzhen VitaVitro Biotech Co.,Ltd510(k) NO: K212410(Traditional)
ATTN: Donghai Pan PHONE NO : 86 755 84511813
R601, Building B, Hai Ke Xing TechSE DECISION MADE: 01-FEB-22
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnifico Open, Magnifico MSK
Esaote S.p.A. 510(k) NO: K212419(Traditional)
ATTN: Alberto Carcagni PHONE NO : 39 055 4229365
Via Enrico Melen 77 SE DECISION MADE: 04-FEB-22
Genoa IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
Biomet, Inc. 510(k) NO: K212431(Traditional)
ATTN: Gregory Foster PHONE NO : 574 3710519
56 East Bell Drive PO Box 587 SE DECISION MADE: 07-FEB-22
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
Hangzhou Sejoy Electronics & Instr510(k) NO: K212447(Traditional)
ATTN: Yanyan Zhang PHONE NO : 86 571 81957767
Area C, Building 2, No.365 SE DECISION MADE: 18-FEB-22
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexitSystem Knee osteotomy system
Neosteo 510(k) NO: K212545(Traditional)
ATTN: JD Webb PHONE NO : 33 02 36569670
Malleve 2A, 1 Boulevard Jean MouliSE DECISION MADE: 11-FEB-22
Nantes FR 44 100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoPlan System
OsteoMed LLC 510(k) NO: K212570(Traditional)
ATTN: Diane Rutherford PHONE NO : 972 6774731
3885 Arapaho Road SE DECISION MADE: 11-FEB-22
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amazing+
Amazing Rubber Products Pvt Ltd 510(k) NO: K212586(Abbreviated)
ATTN: Jayasankar S PHONE NO : 944 7053062
Plot No 14c, Cochin Special EconomSE DECISION MADE: 17-FEB-22
Cochin IN 682037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser Equipment
Beijing Globalipl Development Co.,510(k) NO: K212611(Traditional)
ATTN: Liu Jun PHONE NO : 86 151 69727366
F-8 Qunyinghui Building, Jinyuan RSE DECISION MADE: 01-FEB-22
Beijing CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zyter RPM
Zyter, Inc. 510(k) NO: K212622(Traditional)
ATTN: Lakshmi Narayana Babu PHONE NO : 240 4269647
2600 Tower Oaks Blvd. Suite 700 SE DECISION MADE: 11-FEB-22
Rockville MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True Tulip, True M.I.S.
Innovative Surgical Designs, Inc. 510(k) NO: K212627(Special)
ATTN: Jon Rinehart PHONE NO : 217 8368522 103
3903 S. Walnut St. SE DECISION MADE: 18-FEB-22
Bloomington IN 47401 510(k) STATEMENT
DEVICE: Micro C Medical Imaging System, M01
OXOS Medical, Inc. 510(k) NO: K212654(Third Party - Traditional)
ATTN: Evan Ruff PHONE NO : 855 7339729
1230 Peachtree Street NE, Suite 30SE DECISION MADE: 04-FEB-22
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CloudCath Peritoneal Dialysis Drain Set Monitoring System
CloudCath 510(k) NO: K212658(Traditional)
ATTN: Brian Fisher PHONE NO : 415 6513393
665 3rd Street, Suite 250 SE DECISION MADE: 09-FEB-22
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sclerotherapy Needle
Zhejiang Chuangxiang Medical Techn510(k) NO: K212668(Traditional)
ATTN: Lucius Long PHONE NO : 86 571 89167088
SE DECISION MADE: 23-FEB-22
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Actively Trying Personal Lubricant Unfragrance
CC Wellness LLC 510(k) NO: K212705(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 09-FEB-22
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genex Bone Graft Substitute
Biocomposites Ltd 510(k) NO: K212721(Traditional)
ATTN: Simon Fitzer PHONE NO : 440 1782 338580
Keele Science Park SE DECISION MADE: 04-FEB-22
Keele GB ST5 5NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vacutainer UltraTouch Push Button Blood Collection Set
Becton, Dickinson and Company 510(k) NO: K212724(Traditional)
ATTN: Katherine Kenner Lemus PHONE NO : 732 31448624
1 Becton Drive SE DECISION MADE: 04-FEB-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenSure LightGuide
Intersect ENT 510(k) NO: K212774(Traditional)
ATTN: Yoko Enrile PHONE NO : 650 6813143
1555 Adams Dr. SE DECISION MADE: 04-FEB-22
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LevaLap Laparoscopic Access Device
Core Access Surgical Technologies,510(k) NO: K212786(Traditional)
ATTN: Marianne D. Jacklyn PHONE NO : 503 5037299633
3495 Piedmont Road, NE Building 11SE DECISION MADE: 23-FEB-22
Atlanta GA 30305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMA Humeral System and SMR Glenosphere Ø42
LimaCorporate S.p.A. 510(k) NO: K212800(Traditional)
ATTN: Antonia Trevisan PHONE NO :
Via Nazionale 52 SE DECISION MADE: 25-FEB-22
Villanova di San Daniele del friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bluezone Model RX-450 Air Purifier
Bluezone Products, Inc. 510(k) NO: K212824(Traditional)
ATTN: Karen Benedek PHONE NO : 781 9370202
225 Wildwood Avenue SE DECISION MADE: 17-FEB-22
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Chifeng Huawei Medical Science & T510(k) NO: K212833(Traditional)
ATTN: Li Xiaohong PHONE NO : 86 182 480565694
No. 2-4, Second-stage StandardizedSE DECISION MADE: 28-FEB-22
Chifeng CN 024023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
bioMérieux, Inc 510(k) NO: K212849(Special)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Rd. SE DECISION MADE: 04-FEB-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Taiwan Comfort Champ Manufacturing510(k) NO: K212863(Traditional)
ATTN: Jen Ke-Min PHONE NO : 886 3 3637999
No. 55, Aly. 51, Ln. 50, Daren Rd.SE DECISION MADE: 19-FEB-22
Taoyuan City TW 33068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Actively Trying Personal Lubricant Rose Scented
CC Wellness LLC 510(k) NO: K212885(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 11-FEB-22
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Broncoflex Agile, Broncoflex Vortex, Screeni
Axess Vision Technology 510(k) NO: K212886(Traditional)
ATTN: Marie-Hélène Bacheley PHONE NO : 33 02 47343290
Zone de la Liodière 6, rue de la FSE DECISION MADE: 16-FEB-22
Joué-lès-Tours FR 37300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LumiVy Lumbar IBF System
Vy Spine, LLC 510(k) NO: K212930(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 16-FEB-22
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Pressure Foot Massager
Xiamen Simo Electronic Co., Ltd 510(k) NO: K212935(Traditional)
ATTN: Wang Qinsheng PHONE NO : 86 138 60109615
Floor 3rd-5th, No. 173 Siming ParkSE DECISION MADE: 19-FEB-22
Xia Men CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
Henan Nursecare Biotechnology Co.,510(k) NO: K212949(Abbreviated)
ATTN: Yaping Zhang PHONE NO : 86 373 5698686
Building C1, Xindong Science Park,SE DECISION MADE: 24-FEB-22
Xinxiang CN 453700 510(k) STATEMENT
DEVICE: NPseal
Guard Medical Inc 510(k) NO: K212971(Traditional)
ATTN: Machiel Van Der Leest PHONE NO : 888 4173644
1221 Brickwell Avenue, Suite 900 SE DECISION MADE: 10-FEB-22
Miami FL 33131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
Cordis Corporation 510(k) NO: K212977(Traditional)
ATTN: Vidya Venkataraghavan PHONE NO : 408 7181348
14201 N.W. 60th Avenue SE DECISION MADE: 17-FEB-22
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (White, Blue and Black)
Alcatron Gloves Factory 510(k) NO: K212998(Traditional)
ATTN: Hui Zhao PHONE NO : 0086 533 2197155
NO. 12-1, Xing' an Road East, LinqSE DECISION MADE: 19-FEB-22
Weifang CN 262600 510(k) STATEMENT
DEVICE: Levator Elite (Model LE9011)
Shenzhen Dongdixin Technology Co.,510(k) NO: K213043(Traditional)
ATTN: Siping Yuan PHONE NO : 86 755 27652471
Floor 1-2, No.3 Building, Fanshen SE DECISION MADE: 25-FEB-22
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExamVue Duo
JPI Healthcare Co, Ltd. 510(k) NO: K213057(Traditional)
ATTN: Sam Kang PHONE NO : 82 70 44454516
608-Ho, 28, Digital-Ro 33-Gil, GurSE DECISION MADE: 18-FEB-22
Seoul KR 08377 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O'Star Nitrile Examination Gloves Powder Free
Star Investment And Trade Joint St510(k) NO: K213058(Traditional)
ATTN: Do Van Binh PHONE NO : 84 984 990992____
Khac Niem Industrial Cluster, KhacSE DECISION MADE: 08-FEB-22
Bac Ninh VN 16000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ear Thermometer, Model ET001
Guangzhou Berrcom Medical Device C510(k) NO: K213079(Traditional)
ATTN: Zhigang Du PHONE NO : 86 020 34938449
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 18-FEB-22
Guangzhou CN 51147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ear Thermometer, Model ET005, ET008, ET009
Guangzhou Berrcom Medical Device C510(k) NO: K213084(Traditional)
ATTN: Zhigang Du PHONE NO : 86 020 34938449
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 25-FEB-22
Guangzhou CN 51147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well-Life TENS/EMS/Heating Stimulator
Well-Life Healthcare Limited 510(k) NO: K213091(Traditional)
ATTN: Jenny Hsieh PHONE NO : 886 2 22266981
6F., No.168, Lide St., Jhonghe DisSE DECISION MADE: 19-FEB-22
New Taipei City TW 235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Gloves
Novid PPE Sdn. Bhd. 510(k) NO: K213107(Traditional)
ATTN: Er Chai Chuan PHONE NO : 6 016 3689637
Lot 6071, Jalan Haji Abdul Manan, SE DECISION MADE: 17-FEB-22
Klang MY 41050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid
iSchema View Inc. 510(k) NO: K213165(Traditional)
ATTN: James Rosa PHONE NO : 303 7043374
433 Park Point Drive, Suite 220 SE DECISION MADE: 08-FEB-22
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoFlow Reinforced Ureteral Stent
Coloplast Corp 510(k) NO: K213186(Traditional)
ATTN: Gayatri Ghadge PHONE NO : 612 4223206
1601 West River Road North SE DECISION MADE: 16-FEB-22
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
BioMerieux, Inc. 510(k) NO: K213241(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 25-FEB-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EONS Nitrile Examination Gloves Powder Free
Eons Gloves (Thailand) Co., Ltd 510(k) NO: K213286(Traditional)
ATTN: Gliaophan Supharkarn PHONE NO : 66 958 638585
486/14 Moo 9 Nai Klong Bang Pla KoSE DECISION MADE: 19-FEB-22
Phra Samut Chedi TH 10290 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Redline
Johns Dental Laboratories 510(k) NO: K213297(Traditional)
ATTN: Marni Buis PHONE NO : 800 4570504
423 S. 13th ST SE DECISION MADE: 09-FEB-22
Terre Haute IN 47807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
Zibo Sinocare Plastic Products Co.510(k) NO: K213306(Traditional)
ATTN: Mila Guo PHONE NO : 008 6533 7859433
Lot 5, No. 21 Qingtian Road SE DECISION MADE: 18-FEB-22
Zibo CN 255414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucy Breast Pump
Willow Innovations, Inc. 510(k) NO: K213311(Third Party - Traditional)
ATTN: Nelson Lam PHONE NO : 925 9898681
1975 W. El Camino Real, Suite 306 SE DECISION MADE: 09-FEB-22
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Veinoflow SCD (Model: LBTK-M-I 5006)
Dalian Labtek Science & Developmen510(k) NO: K213313(Traditional)
ATTN: Yao Cui PHONE NO : 86 411 84548445
1-18-17, Liandong Street, AdvancedSE DECISION MADE: 09-FEB-22
Dalian CN 116085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz ANEURYSM, Viz ANX
Viz.ai, Inc. 510(k) NO: K213319(Traditional)
ATTN: Gregory Ramina PHONE NO : 239 8983105
201 Mission St, 12th Floor SE DECISION MADE: 18-FEB-22
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
Stryker GmbH 510(k) NO: K213328(Traditional)
ATTN: Cindy Leon PHONE NO : 201 8315374
325 Corporate Drive SE DECISION MADE: 11-FEB-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INLIANT Surgical Navigation System
Navigate Surgical Technologies Inc510(k) NO: K213392(Traditional)
ATTN: Marty Dymek PHONE NO : 949 3503722
302 - 25 E. 6th Ave. SE DECISION MADE: 22-FEB-22
Vancouver CA V5T 1J3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Luliang Hongruida Health Protectio510(k) NO: K213440(Traditional)
ATTN: Zhang Guocai PHONE NO : 86 311 66766067
Zhaokua Area, Luliang Industrial ZSE DECISION MADE: 18-FEB-22
Qujing CN 655606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzRay M18 (Model: VMX-P400)
Vatech Co., Ltd 510(k) NO: K213462(Traditional)
ATTN: Daniel Kim PHONE NO : 82 31 3799492
13, Samsung 1-ro 2-gil SE DECISION MADE: 11-FEB-22
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON P500 Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K213487(Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 S.E. 51st Street SE DECISION MADE: 11-FEB-22
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMG Nitrile Powder Free Examination Glove
Thai Medical Glove Co., Ltd. 510(k) NO: K213500(Traditional)
ATTN: Noppadol Polbundit PHONE NO : 66 38198102
363/2 Moo 8, Tambol Bangphra SE DECISION MADE: 21-FEB-22
Sriracha TH 20110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
Shenzhen AOJ Medical Technology Co510(k) NO: K213503(Traditional)
ATTN: Queena Chen PHONE NO : 86 755 27786026
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 18-FEB-22
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
Bio Compression Systems, Inc. 510(k) NO: K213533(Traditional)
ATTN: Marc Somelofski PHONE NO : 1 201 9390716
120 West Commercial Ave SE DECISION MADE: 16-FEB-22
Moonachie NJ 07074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Mercator Medical (Thailand) LTD 510(k) NO: K213548(Traditional)
ATTN: Praneet Inthajak PHONE NO : 66 74 584222
88/8 Moo 12 Tambon Kampaengphet SE DECISION MADE: 21-FEB-22
Amphur Rattaphum TH 90180 510(k) STATEMENT
DEVICE: Sentient Manufacturing Laser Fiber
Sentient Manufacturing LLC 510(k) NO: K213554(Traditional)
ATTN: Jim Mousseau PHONE NO : 303 9029891
4384 N Forestdale Dr., Suite 202 SE DECISION MADE: 02-FEB-22
Park City UT 84098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETi AIO Peripheral Thrombectomy System
Walk Vascular, LLC 510(k) NO: K213565(Traditional)
ATTN: Namratha Manthani PHONE NO : 408 2205786
17171 Daimler Street SE DECISION MADE: 01-FEB-22
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLLYWOOD SPECTRA Laser System
Lutronic Corporation 510(k) NO: K213569(Traditional)
ATTN: Haewon Park PHONE NO : 978 4474763
Lutronic Center, 219, Sowon-Ro SE DECISION MADE: 04-FEB-22
Deogyang-gu, Goyang-Si KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELNAC Wound Matrix
Gunze Limited 510(k) NO: K213573(Traditional)
ATTN: Hidenori Nishioka PHONE NO : 81 773 428035
46 Natsumegaichi, Aono SE DECISION MADE: 09-FEB-22
Ayabe, Kyoto JP 623-8513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuperLine
Dentium Co., Ltd. 510(k) NO: K213599(Traditional)
ATTN: Eunsang Lee PHONE NO : 82 070 70987568
76, Changnyong-daero 256beon-gil SE DECISION MADE: 23-FEB-22
Suwon-si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical nitrile examination gloves (Model: SH001)
Jiangxi SanHao Medical Instruments510(k) NO: K213600(Traditional)
ATTN: Wangfenfang No Last Name prPHONE NO : 86 151 79660192
Chengxi Industrial Park, Jishui CoSE DECISION MADE: 19-FEB-22
Ji'an CN 331699 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA Artist Evo
GE Healthcare(Tianjin) Company Lim510(k) NO: K213603(Traditional)
ATTN: Qiang Ding PHONE NO : 86 133 11385163
No. 266 Jinjsan Road, Tianjin AirpSE DECISION MADE: 11-FEB-22
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EvoEndo Single-Use Endoscopy System
EvoEndo Inc 510(k) NO: K213606(Traditional)
ATTN: Heather Underwood PHONE NO : 303 2237445
12649 East Caley Ave, Suite 116 SE DECISION MADE: 14-FEB-22
Centennial CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Megasoft (China) Co., Ltd. 510(k) NO: K213617(Traditional)
ATTN: Sarah Qiu PHONE NO : 86 188 59998002
No.1 Xinqiang Road, Machinery PrinSE DECISION MADE: 11-FEB-22
Shishi CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cionic Neural Sleeve NS-100
CIONIC 510(k) NO: K213622(Traditional)
ATTN: Mihai Ionescu PHONE NO : 831 8244051
1606 Stockton St, Suite #1 SE DECISION MADE: 14-FEB-22
San Francisco CA 94133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Examination Gloves
Dezhou Hengchang Medical Technolog510(k) NO: K213625(Traditional)
ATTN: Jing Li PHONE NO : 86 159 63319855
West Side of South Tiandingfeng RoSE DECISION MADE: 17-FEB-22
Dezhou City CN 251500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instylla Delivery Kit
Instylla, Inc. 510(k) NO: K213632(Special)
ATTN: Jennifer Greer PHONE NO : 781 6229293
201 Burlington Road, North BuildinSE DECISION MADE: 10-FEB-22
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl/Nitrile Blend Exam Glove
Dezhou Hengchang Medical Technolog510(k) NO: K213634(Traditional)
ATTN: Jing Li PHONE NO : 86 159 63319855
West Side of South Tiandingfeng RoSE DECISION MADE: 18-FEB-22
Dezhou City CN 251500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co510(k) NO: K213635(Traditional)
ATTN: Feng Yun PHONE NO : 86 1801 7856052
1/F, Building 12, No.9 Chuanqi WesSE DECISION MADE: 28-FEB-22
Xiangtan CN 411100 510(k) STATEMENT
DEVICE: Durex Patronus Wide
RB Health (US) LLC 510(k) NO: K213647(Traditional)
ATTN: Kaitlyn Chan PHONE NO : 862 3250012
399 Interpace Pkwy SE DECISION MADE: 17-FEB-22
Parsippany NJ 07054-1133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Reline Cervical System
NuVasive, Incorporated 510(k) NO: K213654(Traditional)
ATTN: Sali Gully PHONE NO : 858 9093360
7475 Lusk Boulevard SE DECISION MADE: 23-FEB-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. Braun Introcan Safety 2 IV Catheter
B. Braun Medical Inc. 510(k) NO: K213664(Special)
ATTN: Tracy Larish PHONE NO :
901 Marcon Blvd. SE DECISION MADE: 11-FEB-22
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves (Model: ZMG1351)
Wuhan Zonsen Medical Products Co.,510(k) NO: K213688(Traditional)
ATTN: Cynthia Ye PHONE NO : 86 27 82737771
No 8 Jinchao Road, Zhucheng StreetSE DECISION MADE: 18-FEB-22
Wuhan CN 431400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson P6, Voluson P8
GE Healthcare 510(k) NO: K213689(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 17-FEB-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc510(k) NO: K213693(Traditional)
ATTN: Karthik Pillai PHONE NO : 1 317 3718593
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 25-FEB-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exeter® X3® RimFit® Cup
Howmedica Osteonics Corp., dba Str510(k) NO: K213701(Traditional)
ATTN: Lin Song PHONE NO : 201 2480177
325 Corporate Drive SE DECISION MADE: 01-FEB-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
Intuitive Surgical, Inc. 510(k) NO: K213710(Traditional)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 17-FEB-22
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Hunan Zhenheyikang Medical Instrum510(k) NO: K213724(Traditional)
ATTN: Yilin Yin PHONE NO : 86 0731 58262222
No.6 Building Jingxiang Energy,No.SE DECISION MADE: 20-FEB-22
Xiangtan CN 411100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VyLink™ Spinal Screw System
Vy Spine, LLC 510(k) NO: K213750(Traditional)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 28-FEB-22
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Resorbable Fixation System
Stryker Leibinger Micro Implants 510(k) NO: K213777(Special)
ATTN: Gregory Gohl PHONE NO : 269 3701476
750 Trade Centre Way -Suite 200 SE DECISION MADE: 04-FEB-22
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veuron-Brain-pAb2
Heuron Co., Ltd. 510(k) NO: K213801(Traditional)
ATTN: Dong Hoon Shin PHONE NO : 82 32 4298508
10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 04-FEB-22
lncheon KR 21558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALACOS MV pro
Heraeus Medical GmbH 510(k) NO: K213812(Traditional)
ATTN: Ljuba Jaeckel PHONE NO : 49 6181 353138
Philipp-Reis-Str. 8/13 SE DECISION MADE: 02-FEB-22
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viveve 2.0 System
Viveve, Inc. 510(k) NO: K213814(Traditional)
ATTN: Kevin Robison PHONE NO : 317 4358898
345 Inverness Drive South, BuildinSE DECISION MADE: 02-FEB-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation 510(k) NO: K213824(Special)
ATTN: Thomas Flannelly PHONE NO : 011 353 876487949
4100 East Milham Ave. SE DECISION MADE: 03-FEB-22
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Home use hair removal device, model: Precise Touch Pro
Iluminage Beauty Co., Limited 510(k) NO: K213830(Traditional)
ATTN: Jacky Lee PHONE NO : 86 135 10584309
Level 54, Hopewell Centre, 183 QueSE DECISION MADE: 01-FEB-22
Wan Chai HK 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAVERICK External Fixation System
Smith & Nephew, Inc. 510(k) NO: K213874(Traditional)
ATTN: Brad Sheals PHONE NO : 901 2887141
7135 Goodlett Farms Parkway SE DECISION MADE: 11-FEB-22
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMICRYL Impression Materials
IMICRYL Dis Malzemeleri San. Ve Ti510(k) NO: K213890(Traditional)
ATTN: Husamettin Sonmez PHONE NO : 90 444 7130 120
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 11-FEB-22
KONYA TR 42030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves
Jiangsu Maolin Medical Technology 510(k) NO: K213912(Traditional)
ATTN: Yuan Mao PHONE NO : 86 158 52683277
29 Yuexiang Road, Yuecheng Town SE DECISION MADE: 19-FEB-22
Jiangyin CN 214404 510(k) STATEMENT
DEVICE: DeGen Navigated Instrumentation
DeGen Medical 510(k) NO: K213918(Traditional)
ATTN: Craig Black PHONE NO : 843 9924551
1321-C North Cashua Drive SE DECISION MADE: 09-FEB-22
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Ascend
GE Healthcare Japan Corporation 510(k) NO: K213938(Traditional)
ATTN: He Haibo PHONE NO :
7-127, 4-Chome, Asahigaoka, SE DECISION MADE: 04-FEB-22
Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Annalise Enterprise CXR Triage Pneumothorax
Annalise-AI 510(k) NO: K213941(Traditional)
ATTN: Eric Qin PHONE NO : 61 2 72040817
Level 21, 60 Margaret Street SE DECISION MADE: 24-FEB-22
Sydney AU 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
GE Healthcare Information Technolo510(k) NO: K213972(Third Party - Traditional)
ATTN: James T Turner PHONE NO : 414 4919895
9900 Innovation Dr. SE DECISION MADE: 17-FEB-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Contour ProtégéAI
MIM Software Inc. 510(k) NO: K213976(Special)
ATTN: Lynn Hanigan PHONE NO : 216 4550600
25800 Science Park Drive – Suite 1SE DECISION MADE: 03-FEB-22
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
Pacific Instruments 510(k) NO: K213982(Traditional)
ATTN: Tracy Sullivan PHONE NO : 808 9418880
438 Hobron Ln, Ste 204 SE DECISION MADE: 17-FEB-22
Honolulu HI 96815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enbio S
Enbio Group AG 510(k) NO: K213991(Special)
ATTN: Lukasz Rogowski PHONE NO : 48 605 058629
Eichengasse 3 SE DECISION MADE: 22-FEB-22
Oensingen CH CH-4702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Learning Image Reconstruction
GE Medical Systems, LLC. 510(k) NO: K213999(Traditional)
ATTN: Amy Yang PHONE NO : 414 3513904
3000 N. Grandview Blvd. SE DECISION MADE: 18-FEB-22
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Zirconia Pre-shaded Block
Shenzhen Yurucheng Dental Material510(k) NO: K214003(Traditional)
ATTN: Fiya Liao PHONE NO : 86 177 27849963
101-201, Building 4, No.1 Branch oSE DECISION MADE: 18-FEB-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zirconia Dental Ceramics
Shenzhen Yurucheng Dental Material510(k) NO: K214005(Traditional)
ATTN: Fiya Liao PHONE NO : 86 177 27849963
101-201, Building 4, No.1 Branch oSE DECISION MADE: 18-FEB-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers
Medtronic Sofamor Danek USA, INC. 510(k) NO: K214011(Special)
ATTN: Alex Underberg PHONE NO : 901 3441443
1800 Pyramid Place SE DECISION MADE: 09-FEB-22
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accu-Chek Softclix Blood Lancing System
Roche Diabetes Care, Inc. 510(k) NO: K214022(Traditional)
ATTN: Cameron Smith PHONE NO : 317 6961965
9115 Hague Road SE DECISION MADE: 17-FEB-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14HQ901G-B
LG Electronics Inc. 510(k) NO: K214044(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 318 0665641
77, Sanho-daero SE DECISION MADE: 16-FEB-22
Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radialis PET Camera
Radialis Inc. 510(k) NO: K214062(Third Party - Traditional)
ATTN: Michael Waterston PHONE NO : 1 800 6013177
Suite 2300B, 290 Munro Street SE DECISION MADE: 04-FEB-22
Thunder Bay CA P7A 7T1 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FEops HEARTguide
FEops nv 510(k) NO: K214066(Traditional)
ATTN: Peter Mortier PHONE NO : 32 929 28030
Technologiepark 122 SE DECISION MADE: 25-FEB-22
Gent-Zwijnaarde BE 9052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROKI Surgical Mask
ROKI Co., Ltd. 510(k) NO: K214094(Traditional)
ATTN: Takamasa Murata PHONE NO : 81 53 9260550
2396 Futamata, Futamata-Cho, TenrySE DECISION MADE: 24-FEB-22
Hamamatsu-shi JP 431-3314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Explorer Air II
SurgVision GmbH 510(k) NO: K214097(Traditional)
ATTN: Daniela Mahan PHONE NO : 49 157 85116008
Kistlerhof Strasse 70, Building 79SE DECISION MADE: 25-FEB-22
Munich DE 81379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luminice
Premier North America Inc. 510(k) NO: K214100(Traditional)
ATTN: Ellis Tamari PHONE NO : 404 492813311
3301 SW 42nd Street SE DECISION MADE: 24-FEB-22
Fort Lauderdale FL 33312-6828 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glidewell Appliance Resin, Hard/Soft
Prismatik Dentalcraft, Inc. 510(k) NO: K214102(Traditional)
ATTN: Jiahe Li PHONE NO : 949 2223516
2144 Michelson Drive SE DECISION MADE: 23-FEB-22
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
Mah Sing Healthcare Sdn Bhd 510(k) NO: K214110(Traditional)
ATTN: Sazalinda Musa PHONE NO : 603 3396 2288
Wisma Mah Sing, Penthouse Suite 1,SE DECISION MADE: 19-FEB-22
Kuala Lumpur MY 57100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzOrtho v1.3
Ewoosoft Co., Ltd 510(k) NO: K220003(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 23-FEB-22
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pure-Vu EVS System
Motus GI Medical Technologies Ltd.510(k) NO: K220007(Special)
ATTN: Mark Pomeranz PHONE NO : 908 7458599
22 Keren Ha'yesod Str. SE DECISION MADE: 10-FEB-22
Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cryo 7
Zimmer MedizinSysteme GmbH 510(k) NO: K220020(Special)
ATTN: Ute Killet PHONE NO : 49 731 9761216
Junkersstrasse 9 SE DECISION MADE: 04-FEB-22
Neu-Ulm DE 89231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NightOwl
Ectosense nv 510(k) NO: K220028(Special)
ATTN: Bart Van Pee PHONE NO : 32 2 5889044
Bosbessenlaan 19A SE DECISION MADE: 24-FEB-22
Rotselaar BE 3110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQCross Qx Integrated Transseptal Dilator/Needle
Acutus Medical, Inc. 510(k) NO: K220047(Third Party - Traditional)
ATTN: Sarah Clay PHONE NO : 949 2917811
2210 Faraday Ave, Suite 100 SE DECISION MADE: 08-FEB-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
FUJIFILM Corporation 510(k) NO: K220053(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 04-FEB-22
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
CooperVision, Inc. 510(k) NO: K220070(Special)
ATTN: Marie Dutton PHONE NO :
6101 Bollinger Canyon Road, Suite SE DECISION MADE: 04-FEB-22
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soniquence Reusable Neutral Plate
Soniquence, LLC 510(k) NO: K220071(Special)
ATTN: Suzanne Lucas PHONE NO : 516 6341370
2477 Grand Avenue SE DECISION MADE: 03-FEB-22
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-Pro, Digital Radiography D1
Canon Inc. 510(k) NO: K220098(Special)
ATTN: Akira Hirai PHONE NO : 81 33 7582111
9-1 Imaikami-Cho, Nakahara-Ku SE DECISION MADE: 04-FEB-22
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SDC4K Information Management System with Device and Voice Control Package
Stryker Endoscopy 510(k) NO: K220108(Special)
ATTN: Divya Sekar PHONE NO : 669 2044851
5900 Optical Ct SE DECISION MADE: 09-FEB-22
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YandR System, VoluDerm Handpiece, VoluDerm Tips
Pollogen Ltd. 510(k) NO: K220124(Special)
ATTN: Sharon Ravid PHONE NO : 972 3 5104410
6 Kaufman Street SE DECISION MADE: 17-FEB-22
Tel Aviv IL 6801298 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc. 510(k) NO: K220136(Special)
ATTN: Kristina Hall PHONE NO : 904 3735940
203 Fort Wade Rd., Suite 150 SE DECISION MADE: 16-FEB-22
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lunderquist Extra Stiff Wire Guide
William Cook Europe ApS 510(k) NO: K220137(Special)
ATTN: Mie Dyrholm PHONE NO : 45 56 868492
Sandet 6 SE DECISION MADE: 17-FEB-22
Bjaeverskov DK 4632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspiron S ACP System
U&I Corporation 510(k) NO: K220147(Special)
ATTN: So-yeon Jang PHONE NO : 82 31 8606836
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 16-FEB-22
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS & PMS (Model: SM9126)
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K220150(Third Party - Traditional)
ATTN: Xu Jianhua PHONE NO : 86 755 26423665
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 17-FEB-22
Shenzhen CN 518126 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Hycor Biomedical 510(k) NO: K220162(Traditional)
ATTN: Irene M. Guzman PHONE NO : 714 9333052
7272 Chapman Avenue SE DECISION MADE: 18-FEB-22
Garden Grove CA 92841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trigon HA Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K220197(Special)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 23-FEB-22
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Normatec 3
NormaTec Industries, LP 510(k) NO: K220217(Third Party - Traditional)
ATTN: Steve Henderson PHONE NO : 800 3350960
480 Pleasant Street, Suite A200 SE DECISION MADE: 25-FEB-22
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Megine Industries Sdn Bhd 510(k) NO: K220232(Third Party - Special)
ATTN: Benjamin Ng Soong Jing PHONE NO : 60 112 6808828
B-05-02, The Vertical Business SuiSE DECISION MADE: 20-FEB-22
Kuala Lumpur MY 59200 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Cohitech Cottonlock Tampons with Reusable Applicator
Cotton High Tech, S.L. 510(k) NO: K220238(Special)
ATTN: Anna Garcia Llado PHONE NO : 34 9383 91628
Colonia La Rabeia, S/N SE DECISION MADE: 25-FEB-22
Balsareny ES 08660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Permadyne
3M Deutschland GmbH 510(k) NO: K220257(Third Party - Traditional)
ATTN: Ruediger Franke PHONE NO : 49 815 27001802
ESPE Platz SE DECISION MADE: 01-FEB-22
Seefeld DE 82229 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Digital Intraoral X-ray Sensor
Shenzhen Xpectvision Technology Co510(k) NO: K220277(Traditional)
ATTN: Mengsi Peng PHONE NO : 86 0755 26897621
B507,Block A and B,Nanshan MedicalSE DECISION MADE: 17-FEB-22
Shenzhen CN 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instruments-Electrodes
LivsMed Inc. 510(k) NO: K220384(Special)
ATTN: Dong Wook Lee PHONE NO : 82 70 77094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 24-FEB-22
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apapro Desensitizer
Sangi Co, Ltd 510(k) NO: K220419(Third Party - Traditional)
ATTN: Douglas Mercadante PHONE NO : 81 70 26802931
3-11-6 Tsukiji, Chuo-ku SE DECISION MADE: 16-FEB-22
Tokyo JP 104-8440 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VALO X, VALO X Accessory Lenses
Ultradent Products, Inc. 510(k) NO: K220471(Third Party - Traditional)
ATTN: Adam Black PHONE NO : 801 5534425
505 West Ultradent Drive (10200 SoSE DECISION MADE: 22-FEB-22
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 203
TOTAL WITH SUMMARIES 191
TOTAL WITH STATEMENTS 12
