510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2020
DEVICE: "BoniPlus" Dental G-Mesh System
MontJade Engineering Co., Ltd. 510(k) NO: K182759(Traditional)
ATTN: Yu Sheng Lin PHONE NO : 886 4 23586828
No.2-1, Gongyequ 7th Rd., Xitun DiSE DECISION MADE: 29-JUL-20
Taichung City TW 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IC-WHCD100 (Inspire)
Good Doctors Co.,Ltd. 510(k) NO: K183471(Traditional)
ATTN: Sungro Joo PHONE NO : 82 32 4246325
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 02-JUL-20
Incheon KR 21315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex Fit
DK Mungyo Corporation 510(k) NO: K190790(Traditional)
ATTN: Kang Nae In PHONE NO : 82 055 9052600___
248, Anha-ro, Hallim-myeon SE DECISION MADE: 31-JUL-20
Gimhae-si KR 50852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kendall NPWT Incision Management Dressing Kit
Cardinal Health 510(k) NO: K191101(Traditional)
ATTN: Christine Nuntz-Nassif PHONE NO : 508 6183756
3651 Birchwood Drive SE DECISION MADE: 31-JUL-20
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humelock TiN Coated Glenosphere
FX Shoulder USA, Inc. 510(k) NO: K191146(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 15-JUL-20
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Ti-base Abutment
Dentsply Sirona 510(k) NO: K191152(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 06-JUL-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZCA All-Poly Acetabular Cups
Zimmer, Inc. 510(k) NO: K191449(Traditional)
ATTN: Caleb Barylski PHONE NO : 574 3710250
1800 W. Center Street SE DECISION MADE: 16-JUL-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TiN Coated Humeral Head
FX Shoulder USA, Inc. 510(k) NO: K191698(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 16-JUL-20
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Owgels Oxygen Concentrator
Guangzhou Life Light Electronic Te510(k) NO: K191875(Traditional)
ATTN: Erika Meng PHONE NO : 86 20 87433122
No. A102, No. 1 Kesheng Road, BaiySE DECISION MADE: 20-JUL-20
GUangzhou CN 510540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Glass Ceramics Blocks
Aidite (Qinhuangdao) Technology Co510(k) NO: K192231(Traditional)
ATTN: Zhang Wei PHONE NO : 86 335 8587898
No.9 Dushan Road,Economic and TechSE DECISION MADE: 08-JUL-20
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I Do
I Do Biotech Co., Ltd 510(k) NO: K192294(Traditional)
ATTN: Jae-Hyung Song PHONE NO : 82 53 5812835
#C, 135, Seongseodong-ro, Dalsoe-gSE DECISION MADE: 31-JUL-20
Daegu KR 42721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intravascular Extension Sets and Accessories
Baxter Healthcare Corporation 510(k) NO: K192366(Traditional)
ATTN: Gary Chumbimune PHONE NO : 224 2703312
32650 N. Wilson Road SE DECISION MADE: 20-JUL-20
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
ivWatch, LLC 510(k) NO: K192385(Traditional)
ATTN: Holly Novak PHONE NO : 855 4892824
630 Hofstadter Road, Suite 300 SE DECISION MADE: 02-JUL-20
Newport News VA 23606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KeraStat Cream
KeraNetics 510(k) NO: K192386(Traditional)
ATTN: Luke Burnett PHONE NO : 336 2021307
200 East First Street, Suite 101, SE DECISION MADE: 16-JUL-20
Winston Salem NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psoria-Shield AURORA
Psoria-Shield 510(k) NO: K192411(Special)
ATTN: John Yorke PHONE NO : 866 9919547
409 Mandeville St SE DECISION MADE: 02-JUL-20
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccelFix Lumbar Plate System
L&K Biomed Co., Ltd. 510(k) NO: K192481(Traditional)
ATTN: KiHyang Kim PHONE NO : 82 105477 0325
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 28-JUL-20
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cyber Blade
Sidam s.r.l 510(k) NO: K192499(Traditional)
ATTN: Andrea Tromba PHONE NO : 039 535 25523
Via Statale Sud, 169 SE DECISION MADE: 31-JUL-20
Mirandola (BO) IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
Venner Medical (Singapore) PTE Ltd510(k) NO: K192511(Traditional)
ATTN: Adrian P Waterton PHONE NO : 65 6511 2350
35 Joo Koon Circle SE DECISION MADE: 22-JUL-20
Singapore SG 629110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUS SUS20
Saeshin Precision Co., Ltd. 510(k) NO: K192561(Traditional)
ATTN: DongHa Lee PHONE NO :
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 13-JUL-20
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Joimax Intracs System
joimax GmbH 510(k) NO: K192663(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
Amalienbadstr. 41, RaumFabrik 61 SE DECISION MADE: 30-JUL-20
Karlsruhe DE 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Extremely Thin 003, ZERO ZERO THREE
Okamoto U.S.A., Inc. 510(k) NO: K192669(Abbreviated)
ATTN: Yu Tadano PHONE NO : 203 3780003 301
18 King Street SE DECISION MADE: 24-JUL-20
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
Jiangsu Kangbao Medical Experiment510(k) NO: K192681(Traditional)
ATTN: Rujun Tang PHONE NO : 86 514 88223540
78#, North Suzhong Road Baoying SE DECISION MADE: 28-JUL-20
Yangzhou CN 225800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
Olympus Medical Systems Corp. 510(k) NO: K192793(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42642 2694
2951 Ishikawa-cho SE DECISION MADE: 17-JUL-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOLIGN
Diorco Co., Ltd. 510(k) NO: K192847(Traditional)
ATTN: Yongkyu Jin PHONE NO : 82 705030 3037
4F, 26 Yeongil-ro, Yeongtong-gu SE DECISION MADE: 21-JUL-20
Suwon-si KR 16705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ulrichINJECT CT Motion
ulrich GmbH & Co. KG 510(k) NO: K192872(Traditional)
ATTN: Sven Erdmann PHONE NO : 49 731 96541714
Buchbrunnenweg 12 SE DECISION MADE: 02-JUL-20
Ulm DE 89081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InferRead Lung CT.AI
Beijing Infervision Technology Co.510(k) NO: K192880(Traditional)
ATTN: Xiaoyan Fan PHONE NO : 86 10 86462323
Haidian District SE DECISION MADE: 02-JUL-20
Beijing CN 100085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optiflux Enexa F500 Dialyzer
Fresenius Medical Care Reanal Ther510(k) NO: K192928(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 09-JUL-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ezra Plexo Software
Ezra AI Inc. 510(k) NO: K192969(Traditional)
ATTN: David Girard PHONE NO : 905 8189142
79 Madison Ave., Ste 545 SE DECISION MADE: 10-JUL-20
New York NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragon 28 APEX 3D Total Ankle Replacement System
Paragon 28, Inc. 510(k) NO: K192994(Traditional)
ATTN: Eric Lintula PHONE NO : 888 7281888
4B Inverness Ct. E., STE 280 SE DECISION MADE: 10-JUL-20
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed BRK Transseptal Needle
Innovative Health, LLC. 510(k) NO: K192998(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 22-JUL-20
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Retractable Safety Insulin Syringe
Jiangsu Caina Medical Co.,Ltd. 510(k) NO: K193022(Traditional)
ATTN: Xinyan Ruan PHONE NO : 86 510 86391266
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 20-JUL-20
Jiangyin CN 214425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOTRAP III Revascularization Device
Neuravi, Ltd. 510(k) NO: K193063(Traditional)
ATTN: Niall Fox PHONE NO : 353 86 1730678
Block 3, Ballybrit Business Park, SE DECISION MADE: 14-JUL-20
Galway IE H91 K5YD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Recon
Shanghai United Imaging Healthcare510(k) NO: K193073(Traditional)
ATTN: Shumei Wang PHONE NO : 86 21 67076888 6776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 06-JUL-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K193097(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 14-JUL-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC Temp Print
GC America Inc. 510(k) NO: K193113(Traditional)
ATTN: Mark Heiss PHONE NO : 708 5970900
3737 W. 127th Street SE DECISION MADE: 09-JUL-20
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luna XD Ti Interbody Fusion System
Benvenue Medical, Inc. 510(k) NO: K193172(Traditional)
ATTN: Laurent Schaller PHONE NO : 408 4549300
4590 Patrick Henry Dr. SE DECISION MADE: 02-JUL-20
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cryocheck Chromogenic Factor VIII
Precision BioLogic 510(k) NO: K193204(Traditional)
ATTN: Karen Black PHONE NO : 902 4686422
140 Eileen Stubbs Avenue SE DECISION MADE: 17-JUL-20
Dartmouth CA B3B 0A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carto Octaray Mapping Catheter with Trueref Technology
Biosense Webster, Inc. 510(k) NO: K193237(Traditional)
ATTN: Richard Lauhead PHONE NO : 949 7898583
33 Technology Dr SE DECISION MADE: 31-JUL-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour ProtegeAI
MIM Software Inc. 510(k) NO: K193252(Traditional)
ATTN: Lynn Hanigan PHONE NO : 216 4550600
25800 Science Park Drive - Suite 1SE DECISION MADE: 02-JUL-20
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
Little Doctor Electronic (Nantong)510(k) NO: K193259(Traditional)
ATTN: Iris Du PHONE NO : 86 0513 80580127
No.14, Zhenxingxilu Road, ChongchuSE DECISION MADE: 02-JUL-20
Nantong CN 226000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GTK Trocars
Guangzhou TK Medical Instrument Co510(k) NO: K193272(Traditional)
ATTN: Tracy Weng PHONE NO : 86 20 32290169
A601, Guangzhou International BusiSE DECISION MADE: 09-JUL-20
Guangzhou CN 510663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM On.site and On.scene
Siemens Medical Solutions USA, Inc510(k) NO: K193277(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 22-JUL-20
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion Prostate MR
Siemens Medical Solutions USA Inc.510(k) NO: K193283(Traditional)
ATTN: Lauren Bentley PHONE NO : 1 610 2416736
40 Liberty Blvd. Mail Code 65-3 SE DECISION MADE: 30-JUL-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion Engine
Siemens Medical Solutions USA, Inc510(k) NO: K193294(Traditional)
ATTN: Lauren Bentley PHONE NO : 1 610 2416736
40 Liberty Blvd. Mail Code 65-3 SE DECISION MADE: 10-JUL-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MY01 Continuous Compartmental Pressure Monitor
MY01, Inc. 510(k) NO: K193321(Traditional)
ATTN: Charles Allan PHONE NO : 855 7996901
85 Rue Saint-Paul Ouest, Suite 200SE DECISION MADE: 30-JUL-20
Montreal CA H2Y 3V4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex DynaNite Compression Plate
Arthrex Inc. 510(k) NO: K193345(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 08-JUL-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
Codman & Shurtleff, Inc. 510(k) NO: K193380(Traditional)
ATTN: Kirsten Franco PHONE NO : 484 8687991
325 Paramount Drive SE DECISION MADE: 20-JUL-20
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioSiCar Silicone Implant
Metalware Technology Corp. 510(k) NO: K193392(Traditional)
ATTN: Megan Chang PHONE NO : 886 2866 72878
10F, No. 117, Minquan Rd., XindianSE DECISION MADE: 20-JUL-20
New Taipei City TW 231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FractureDetect (FX)
Imagen Technologies, Inc. 510(k) NO: K193417(Traditional)
ATTN: Robert Lindsey PHONE NO : 917 8304721
WeWork, 524 Broadway, 8th Floor SE DECISION MADE: 30-JUL-20
New York NY 10012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA LUMEX AC
VITA Zahnfabrik GmbH H Rauter & Co510(k) NO: K193434(Traditional)
ATTN: Bernd Walker PHONE NO : 49 7761 562384
Spitelgasse 3 SE DECISION MADE: 21-JUL-20
Bad Sackingen DE D-79713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Seed™ Fertility Lubricant
Church & Dwight Co., Inc. 510(k) NO: K193450(Traditional)
ATTN: Joelle Reinson PHONE NO : 609 8061671
500 Charles Ewing Blvd. SE DECISION MADE: 23-JUL-20
Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor
Ningbo Ranor Medical Science & Tec510(k) NO: K193456(Traditional)
ATTN: Emma Hu PHONE NO : 86 574 89258788
No. 127 Fenghui Road, Wangchun IndSE DECISION MADE: 16-JUL-20
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC Fuji Triage EP
GC America Inc. 510(k) NO: K193484(Traditional)
ATTN: Mark Heiss PHONE NO : 708 9263090
3737 W. 127th Street SE DECISION MADE: 02-JUL-20
Alsip IL 607803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mako Total Knee Application
Mako Surgical Corp. 510(k) NO: K193515(Traditional)
ATTN: Shikha Khandelwal PHONE NO : 201 8316921
2555 Davie Rd SE DECISION MADE: 14-JUL-20
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA 15 Insufflator
Palliare Ltd. 510(k) NO: K193520(Traditional)
ATTN: John O'Dea PHONE NO : 353 91 516362
Galway Business Park, Dangan SE DECISION MADE: 23-JUL-20
Galway IE H91 92DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syringe with safety needle, Safety needle
Jiangsu Caina Medical Co., Ltd 510(k) NO: K193526(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 8686666680
No.23,Huanxi Rd. Zhutang Town SE DECISION MADE: 17-JUL-20
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empty EVA Bag
Haemotronic, Spa 510(k) NO: K193528(Traditional)
ATTN: Paola Franciosi PHONE NO : 39 0535 619611
16, Via Carreri SE DECISION MADE: 22-JUL-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NextAR TKA Platform
Medacta Inernational SA 510(k) NO: K193559(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 10-JUL-20
Castel San Pietro CH cH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SutureTape
Arthrex Inc. 510(k) NO: K193575(Traditional)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 24-JUL-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Electrosurgical Knife
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K193601(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road SE DECISION MADE: 24-JUL-20
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Benesta Medical Sterilization Tray
Caldera Medical, Inc 510(k) NO: K193603(Traditional)
ATTN: Vicki Gail PHONE NO : 818 8796555
5171 Clareton Drive SE DECISION MADE: 20-JUL-20
Agoura Hills CA 91301 510(k) STATEMENT
DEVICE: BOBBY Balloon Guide Catheter
MicroVention, Inc. 510(k) NO: K193607(Traditional)
ATTN: Stephanie Onstot PHONE NO : 714 2478000 8317
35 Enterprise SE DECISION MADE: 21-JUL-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Upper Arm Blood Pressure Monitor
Dongguan E-Test Technology Co., Lt510(k) NO: K193624(Traditional)
ATTN: Victor Wan PHONE NO : 86 076981 158038
Room 201, 301. Building 1, ChangpiSE DECISION MADE: 10-JUL-20
Dongguan CN 523588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Temperature Probe
Shenzhen Changke Connect Electroni510(k) NO: K193625(Traditional)
ATTN: Yahui Zhou PHONE NO : 86 136 13012560
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 24-JUL-20
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Upper Arm Blood Pressure Monitor
Dongguan E-Test Technology Co., LT510(k) NO: K193627(Traditional)
ATTN: Victor Wan PHONE NO : 86 0769 81158038
Room 201,301. Building 1, ChangpinSE DECISION MADE: 12-JUL-20
Dongguan CN 523588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGE Automatic Wrist Blood Pressure Monitor
Dongguan E-Test Technology Co., Lt510(k) NO: K193628(Traditional)
ATTN: Victor Wan PHONE NO : 86 0769 81158038
Room 201, 301. Building 1, ChangpiSE DECISION MADE: 12-JUL-20
Dongguan CN 523588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Superpipe Angiographic Catheter
Suzhou Hengrui Disheng Medical Co.510(k) NO: K193647(Traditional)
ATTN: Li Ling PHONE NO : 86 512 68050607
No. 11 Building, No.8 Jinfeng RoadSE DECISION MADE: 29-JUL-20
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber™ Compression Screws
Ossio Ltd. 510(k) NO: K193660(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 30-JUL-20
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P pro Crown & Bridge
DeltaMed GmbH 510(k) NO: K200039(Traditional)
ATTN: Michael Zimmerman PHONE NO : 49 6031 728317
Raiffeisenstrasse 8a SE DECISION MADE: 31-JUL-20
Friedberg DE 61169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExcelsiusGPS Cranial 1.0 Module
Globus Medical Inc. 510(k) NO: K200047(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 10-JUL-20
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed NRG Transseptal Needle
Innovative Health, LLC. 510(k) NO: K200060(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 30-JUL-20
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
Galil Medical Inc. 510(k) NO: K200061(Traditional)
ATTN: Amy Mckinney PHONE NO : 651 4020008
4364 Round Lake Road SE DECISION MADE: 09-JUL-20
Arden Hills MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AeroEclipse* ONE BAN
Trudell Medical International 510(k) NO: K200063(Abbreviated)
ATTN: Marianne Tanton PHONE NO : 1 519 4557060
725 Baransway Drive SE DECISION MADE: 17-JUL-20
London CA N5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Univia RightFit Enteral Extension Sets and Transitional Adapters
MPS Medical, Inc. 510(k) NO: K200082(Traditional)
ATTN: Barry Kazemi PHONE NO : 844 6413814
830 Challenger Street, Suite 200 SE DECISION MADE: 30-JUL-20
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
PENTAX of America, Inc. 510(k) NO: K200090(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 23-JUL-20
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Versana Premier
GE Medical Systems Ultrasound and 510(k) NO: K200138(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
Primary Care Diagnostics LLC 9900 SE DECISION MADE: 01-JUL-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpeediCath Soft
Coloplast 510(k) NO: K200142(Traditional)
ATTN: Delaney McDougal PHONE NO : 612 3808034
1601 West River Road North SE DECISION MADE: 30-JUL-20
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&J DVT Compression Devices MHH800/MHH800SQ
B & J Manufacturing Ltd. 510(k) NO: K200154(Traditional)
ATTN: Billy Yu PHONE NO : 86 0755 88210239
Room 701 & 101, Building 24, BlockSE DECISION MADE: 08-JUL-20
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrascanner
InfraScan, Inc. 510(k) NO: K200203(Traditional)
ATTN: Baruch Ben Dor PHONE NO : 215 3876784
3508 Market Street SE DECISION MADE: 10-JUL-20
Philadelphia PA 19104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digiscan FDX
Allengers Medical Systems Limited 510(k) NO: K200218(Traditional)
ATTN: Sanjeev K. Marjara PHONE NO : 91 1762 282600
FDA Hall, Unit 11 Bhankharpur, MubSE DECISION MADE: 13-JUL-20
Derabassi, Distt Mohali IN 140507510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StaClear Syringe
TriboFilm Research, Inc. 510(k) NO: K200242(Traditional)
ATTN: Jackson Thornton PHONE NO : 919 8382844
625 Hutton Street SE DECISION MADE: 27-JUL-20
Raleigh NC 27606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
Allwin Medical Devices, Inc. 510(k) NO: K200248(Traditional)
ATTN: Digish Mehta PHONE NO : 714 5721709
3305 East Mira Loma Avenue, STE 17SE DECISION MADE: 01-JUL-20
Anaheim CA 92806 510(k) STATEMENT
DEVICE: MEDRAD Imaging Bulk Package Transfer Spike
Bayer Medical Care Inc. 510(k) NO: K200280(Traditional)
ATTN: Leslie S O'Nan PHONE NO : 412 4063165
1 Bayer Drive SE DECISION MADE: 30-JUL-20
Indianola PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenaOne
Vena Group, LLC 510(k) NO: K200285(Traditional)
ATTN: Kasey Vukson PHONE NO : 210 4224613
10 Westelm Gardens SE DECISION MADE: 02-JUL-20
San Antonio TX 78230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orbit Subretinal Delivery System
Orbit Biomedical 510(k) NO: K200325(Traditional)
ATTN: Stacey Backlund PHONE NO : 267 9807991
300 Brookside Ave. SE DECISION MADE: 14-JUL-20
Ambler PA 19002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RC-Prime Root Canal Preparation Cream
Pac-Dent, Inc 510(k) NO: K200330(Traditional)
ATTN: Daniel Wang PHONE NO : 909 8390888
670 Endeavor Circle SE DECISION MADE: 06-JUL-20
Brea CA 92821 510(k) STATEMENT
DEVICE: Duranext Abutments
Elegant Dental Corp. 510(k) NO: K200355(Traditional)
ATTN: Gary Fingerman PHONE NO : 718 3755999
2308 McDonald Avenue SE DECISION MADE: 22-JUL-20
Brooklyn NY 11223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wiggins Medical Surgical Instruments
Wiggins Medical 510(k) NO: K200383(Traditional)
ATTN: Alex Ebner PHONE NO : 800 4970851
2230 Park Avenue #202 SE DECISION MADE: 21-JUL-20
Cincinnati OH 45206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ace Medical Surgical Instruments
Ace Medical 510(k) NO: K200387(Traditional)
ATTN: Alex Ebner PHONE NO : 513 3210055
2230 Park Ave. #202 SE DECISION MADE: 21-JUL-20
Cincinnati OH 45206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REXSIN
SM ENG CO., LTD 510(k) NO: K200392(Traditional)
ATTN: Soon-Gu Lee PHONE NO : 82 51 3058016
46, Nakdong-daero 1302beon-gil SE DECISION MADE: 07-JUL-20
Sasang-gu KR 46910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pelvital System
Pelvital USA, Inc. 510(k) NO: K200409(Traditional)
ATTN: Dale Wahlstrom PHONE NO : 612 8041319
1000 LaSalle Avenue, SCH 435 SE DECISION MADE: 10-JUL-20
Minneapolis MN 55403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symphony
Aroa Biosurgery Ltd. 510(k) NO: K200413(Traditional)
ATTN: Tina O'Brien PHONE NO : 64 09 8693035 214
2 Kingsford Smith Place SE DECISION MADE: 29-JUL-20
Airport Oaks NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonicision Cordless Ultrasonic Dissector
Covidien, llc 510(k) NO: K200427(Special)
ATTN: Celso Duran PHONE NO : 303 5306445
5920 Longbow Dr. SE DECISION MADE: 10-JUL-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Cube 90
Alpinion Medical Systems Co., Ltd.510(k) NO: K200449(Traditional)
ATTN: Boyeon Cho PHONE NO : 82 70 74652104
5FL, I dong, 77, heungan-daero 81 SE DECISION MADE: 10-JUL-20
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Cube 70
Alpinion Medical Systems Co., Ltd.510(k) NO: K200450(Traditional)
ATTN: Boyeon CHO PHONE NO : 82 70 74652104
5FL, I dong, 77, heungan-daero 81 SE DECISION MADE: 10-JUL-20
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LG Pra. L Derma LD Scalp Care
LG Electronics, Inc. 510(k) NO: K200464(Traditional)
ATTN: Eunmi Ji PHONE NO : 82 31 6864676
222 LG-ro Jinwi-myeon SE DECISION MADE: 23-JUL-20
Pyeongtaek-si KR 17709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DreamStation 2 System, DreamStation 2 Advanced System
Respironics, Inc. 510(k) NO: K200480(Traditional)
ATTN: Andy Zaltwanger PHONE NO : 724 5796095
1001 Murry Ridge Lane SE DECISION MADE: 10-JUL-20
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aer X
3B Medical Inc. 510(k) NO: K200496(Special)
ATTN: Yasser Estafanous PHONE NO : 863 2266285
203 Avenue A NW, Suite 300 SE DECISION MADE: 24-JUL-20
Winter Haven FL 33881 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and 510(k) NO: K200497(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 16-JUL-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCENARIA View
Hitachi Healthcare Americas 510(k) NO: K200498(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 17-JUL-20
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
MED-EL Elektromedizinische Geraete510(k) NO: K200504(Traditional)
ATTN: Carolin Ralser PHONE NO : 43 577 881268
Fuerstenweg 77a SE DECISION MADE: 29-JUL-20
Innsbruck AT 6020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAC Dynamic Active Compression Plate
Pioneer Surgical Technology, Inc.,510(k) NO: K200513(Traditional)
ATTN: Linda Busklein PHONE NO : 855 4551061 7961
375 River Park Circle SE DECISION MADE: 22-JUL-20
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pitkar External Fixation System - Rail Mechanism
S H Pitkar Orthotools Pvt Ltd 510(k) NO: K200518(Traditional)
ATTN: Vivek Mangalwedhekar PHONE NO : 91 204 0706464
Plot No. EL 32, J Block, MIDC BhosSE DECISION MADE: 29-JUL-20
Pune IN 411026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHealth Infrared No-Touch Forehead Thermometer
Andon Health Co., Ltd. 510(k) NO: K200531(Traditional)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 15-JUL-20
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxxiom
True Wearables, Inc. 510(k) NO: K200537(Traditional)
ATTN: Marcelo Lamego PHONE NO : 760 7109712
29826 Avenida de Las Banderas, SuiSE DECISION MADE: 03-JUL-20
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
Olympus Medical Systems Corp. 510(k) NO: K200542(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 17-JUL-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitalograph Model 2120 In2itive eDiary
Vitalograph Ireland Ltd. 510(k) NO: K200550(Traditional)
ATTN: Tony O'Hanlon PHONE NO : 353 65 6864100
Gort Road Business Park SE DECISION MADE: 27-JUL-20
Ennis Co Clare IE V95 HFT4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimPlus Patch, StimPlus Patch, StimPlus Patch
JKH Health Co., LTD 510(k) NO: K200561(Special)
ATTN: Pu Jiang PHONE NO : 86 755 27926589
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 01-JUL-20
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
B & J Manufacturing Ltd 510(k) NO: K200568(Traditional)
ATTN: Billy Yu PHONE NO : 86 0755 88210239
Room 701 & 101, Building 24, BlockSE DECISION MADE: 10-JUL-20
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer Model Number RN-50A,RN-50B
Ningbo Ranor Medical Science & Tec510(k) NO: K200578(Traditional)
ATTN: Emma Hu PHONE NO : 86 574 89258788
No. 127 Fenghui Road, Wangchun IndSE DECISION MADE: 16-JUL-20
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: xPORT 304 (miCOR) System Lens Fragmentation System
Carl Zeiss Meditec Cataract Techno510(k) NO: K200584(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
8748 Technology Way SE DECISION MADE: 31-JUL-20
Reno NV 89521 510(k) STATEMENT
DEVICE: Digital Thermometer
Joytech Healthcare Co., Ltd 510(k) NO: K200599(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No. 365, Wuzhou Road, Yuhang EconoSE DECISION MADE: 08-JUL-20
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caption Interpretation Automated Ejection Fraction Software
Caption Health 510(k) NO: K200621(Traditional)
ATTN: Sam Surette PHONE NO : 571 3356532
2000 Sierra Point Pkwy SE DECISION MADE: 22-JUL-20
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR-8100 Portable X-ray Unit
Shantou Institute of Ultrasonic In510(k) NO: K200637(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 09-JUL-20
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
Shenzhen Mindray Bio-Medical Elect510(k) NO: K200643(Traditional)
ATTN: Jiang Xiaoyong PHONE NO : 86 7558 1886238
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 24-JUL-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lollipop BiteBlock
RadTec Medical Devices, Inc. 510(k) NO: K200652(Traditional)
ATTN: Ross Holman PHONE NO : 844 7238321
131 Glenn Way #7 SE DECISION MADE: 06-JUL-20
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rubicon SA System
Dymedix Diagnostics, Inc. 510(k) NO: K200654(Traditional)
ATTN: Jim Moore PHONE NO : 888 2121100
5985 Rice Creek Parkway SE DECISION MADE: 22-JUL-20
Shoreview MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroScan® 630
Echosens 510(k) NO: K200655(Traditional)
ATTN: Karine Bonenfant PHONE NO : 33 144 827856
6 rue Ferrus SE DECISION MADE: 16-JUL-20
Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta Multihole TT Pro Acetabular System
Limacorporate S.P.A. 510(k) NO: K200656(Traditional)
ATTN: Michela Zanotto PHONE NO : 39 04329 45511
Via Nazionale, 52 SE DECISION MADE: 08-JUL-20
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
Atrility Medical, LLC 510(k) NO: K200674(Abbreviated)
ATTN: Matthew Knoespel PHONE NO : 920 6198737
313 Price Place, Suite 13 SE DECISION MADE: 02-JUL-20
Madison WI 53705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
Zirkonzahn srl 510(k) NO: K200676(Traditional)
ATTN: Julian Steger PHONE NO : 39 0474 066660
Via An der Ahr 7 SE DECISION MADE: 08-JUL-20
Gais IT 39030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Bronchoscope EB-J10 Series
PENTAX of America, Inc. 510(k) NO: K200678(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 30-JUL-20
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synvitro Hyadase
Origio a/s, a CooperSurgical Compa510(k) NO: K200680(Special)
ATTN: Monika Bak PHONE NO : 45 6019 0206
Knardrupvej 2 SE DECISION MADE: 17-JUL-20
Malov DK 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeSignals ECG Remote Monitoring Patch Platform
LifeSignals, Inc. 510(k) NO: K200690(Traditional)
ATTN: Saravanan Balasubramanian PHONE NO : 510 7706412 4
39355 California Street, Suite 305SE DECISION MADE: 15-JUL-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K200738(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277000
Espenstrasse 139 SE DECISION MADE: 23-JUL-20
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-CP610 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K200742(Traditional)
ATTN: Zilong Liang PHONE NO : 0086 25833 05050
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 24-JUL-20
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid E80/ Vivid E90/ Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K200743(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
Primary Care Diagnostics, LLC 9900SE DECISION MADE: 23-JUL-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Steam Chemical Integrator Test Pack
3M Company 510(k) NO: K200766(Traditional)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 02-JUL-20
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stratum™ Reduced Size Foot Plating System
Nextremity Solutions, Inc. 510(k) NO: K200785(Traditional)
ATTN: Adam Finley PHONE NO : 574 8076150
210 North Buffalo Street SE DECISION MADE: 27-JUL-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigation Enabled Intruments
Medos International, SARL 510(k) NO: K200791(Traditional)
ATTN: Daria Bochenek PHONE NO : 41 61 9656154
Chemin-Blanc 38 SE DECISION MADE: 31-JUL-20
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
Medtronic, Inc. 510(k) NO: K200795(Traditional)
ATTN: Eric Kalmes PHONE NO : 763 5262809
8200 Coral Sea Street NE SE DECISION MADE: 03-JUL-20
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantisal Oral Fluid Collection Device
Immunalysis Corporation 510(k) NO: K200801(Traditional)
ATTN: Wenying (Jessica) Zhu PHONE NO : 909 4820480
829 Towne Center Drive SE DECISION MADE: 28-JUL-20
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAR and BEAR mini
FOREO, Inc. 510(k) NO: K200803(Traditional)
ATTN: Laura HoShue PHONE NO : 561 2674702
1525 E. Pama Lane SE DECISION MADE: 31-JUL-20
Las Vegas NV 89119 510(k) STATEMENT
DEVICE: Neocis Guidance System (NGS) with Patient Splints
Neocis Inc. 510(k) NO: K200805(Traditional)
ATTN: Thomas E. Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 28-JUL-20
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3DMax MID Anatomical Mesh
C.R. Bard, Inc. 510(k) NO: K200818(Traditional)
ATTN: Shannon Green PHONE NO : 401 8258774
100 Crossings Boulevard SE DECISION MADE: 17-JUL-20
Warwick RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer, Inc. Hip Joint Prostheses MR Labeling I
Zimmer, Inc. 510(k) NO: K200823(Traditional)
ATTN: Caleb Barylski PHONE NO : 574 3710250
P.O. Box 708 SE DECISION MADE: 09-JUL-20
Warsaw IN 46861-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
Cardinal Health 200, LLC 510(k) NO: K200824(Traditional)
ATTN: Caroline Miceli PHONE NO : 312 2702013
3651 Birchwood Drive SE DECISION MADE: 29-JUL-20
Waukegan IL 60085 510(k) STATEMENT
DEVICE: Safey Peak Flow Meter
Safey Medical Devices Pvt Ltd 510(k) NO: K200832(Traditional)
ATTN: Taher Ali Moiyed PHONE NO : 91 98304 55253
3rd Floor, Office 303, Nyati EmporSE DECISION MADE: 30-JUL-20
Pune IN 411045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8ch Flex Suite
Shenzhen RF Tech Co., Ltd. 510(k) NO: K200836(Traditional)
ATTN: Gary Wang PHONE NO : 0086 755266 41989113
2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 22-JUL-20
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tempus LS - Manual
Remote Diagnostic Technologies, Lt510(k) NO: K200849(Traditional)
ATTN: Martin Newman PHONE NO : 44 01 256362400
Pavilion C2, Ashwood Park, AshwoodSE DECISION MADE: 24-JUL-20
Basingstoke GB RG23 8BG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fujifilm Ultrasonic Processor
FUJIFILM Corporation 510(k) NO: K200850(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 06-JUL-20
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie SAS 510(k) NO: K200856(Traditional)
ATTN: Peter Kelley PHONE NO : 978 6974364
300 Brickstone Square, Suite 203 SE DECISION MADE: 10-JUL-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gamma3 System
Stryker Trauma GmbH 510(k) NO: K200869(Traditional)
ATTN: Sanja Jahr PHONE NO : 201 8316797
325 Corporate Drive SE DECISION MADE: 22-JUL-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
Stryker GmbH 510(k) NO: K200880(Traditional)
ATTN: Jackie Perri PHONE NO : 732 7705616
325 Corporate Drive SE DECISION MADE: 01-JUL-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agape Cooling Personal Lubricant
CC Wellness LLC 510(k) NO: K200894(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 02-JUL-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthMammo
Zebra Medical Vision Ltd. 510(k) NO: K200905(Traditional)
ATTN: Flair Bar PHONE NO : 972 9 8827795
Shefayim Commercial Center, PO BoxSE DECISION MADE: 16-JUL-20
Shefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transept Cervical Plate System
Neurostructures, Inc. 510(k) NO: K200927(Traditional)
ATTN: Moti Altarac PHONE NO : 800 3526103
199 Technology Dr. Suite 110 SE DECISION MADE: 24-JUL-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid LVO
iSchemaView Inc. 510(k) NO: K200941(Traditional)
ATTN: Jim Rosa PHONE NO : 303 7043374
433 Park Point Drive, Suite 220 SE DECISION MADE: 09-JUL-20
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode System with the Morhpeus8 Applicators
InMode Ltd. 510(k) NO: K200947(Traditional)
ATTN: Amit Goren PHONE NO :
Tabor Building, Shaar Yokneam SE DECISION MADE: 02-JUL-20
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Vascutek Ltd 510(k) NO: K200955(Traditional)
ATTN: Heidi Forsyth PHONE NO : 44 141 8125555
Newmains Avenue SE DECISION MADE: 08-JUL-20
Inchinnan GB PA4 9RR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
Biomet UK Ltd. 510(k) NO: K200959(Traditional)
ATTN: Caleb Barylski PHONE NO : 574 3710250
Waterton Industrial Estate SE DECISION MADE: 29-JUL-20
Brigend GB CF31 3XA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
Medline Industires, Inc. 510(k) NO: K200960(Traditional)
ATTN: Adam Ostrower PHONE NO : 224 9311513
Three Lakes Drive SE DECISION MADE: 13-JUL-20
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodesign Staple Line Reinforcement
Cook Biotech Incorporated 510(k) NO: K201000(Traditional)
ATTN: Nick Wang PHONE NO : 765 4973355
1425 Innovation Place SE DECISION MADE: 13-JUL-20
West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safey Pocket Spirometer
Safey Medical Devices Pvt Ltd 510(k) NO: K201002(Traditional)
ATTN: Taher Ali Moiyed PHONE NO : 91 983 0455253
3rd Floor, Office 303, Nyati EmporSE DECISION MADE: 30-JUL-20
Pune IN 411045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FullFocus
Paige.AI, Inc 510(k) NO: K201005(Traditional)
ATTN: Jillian Sue PHONE NO : 646 8495088
11 Times Square, 37th Floor SE DECISION MADE: 15-JUL-20
New York NY 10036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encision AEM enTouch 2X Scissor
Encision Inc. 510(k) NO: K201018(Special)
ATTN: Pete Geary PHONE NO : 303 4442600
6797 Winchester Circle SE DECISION MADE: 15-JUL-20
Boulder CO 80260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHICON Linx Esophagus Sizing Tool
Torax Medical, Inc. 510(k) NO: K201035(Traditional)
ATTN: Joseph Ciccone PHONE NO : 908 2182853
4188 Lexington Avenue, N SE DECISION MADE: 09-JUL-20
Shoreview MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bioflux Software II
Biotricity 510(k) NO: K201040(Traditional)
ATTN: Spencer LaDow PHONE NO : 1 650 8321626
275 Shoreline Drive, Suite 150 SE DECISION MADE: 29-JUL-20
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROBEAT-CR
Hitachi Ltd. 510(k) NO: K201042(Traditional)
ATTN: Tomoyuki Seino PHONE NO : 81 4 71314280
2-1, Shintoyufuta SE DECISION MADE: 13-JUL-20
Kashiwa-shi JP 277-0804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SherpaPak Pediatric Liver Transport System
Paragonix Technologies 510(k) NO: K201048(Traditional)
ATTN: Lisa Anderson PHONE NO : 617 8177790
Suite 408, 639 Granite Street SE DECISION MADE: 02-JUL-20
Braintree MA 02184 510(k) STATEMENT
DEVICE: S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K201059(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
Room 201 & 202, 12th Building, SheSE DECISION MADE: 30-JUL-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V30 System, V20 System, V10 System, V-FR Handpiece
Viora Ltd. 510(k) NO: K201064(Traditional)
ATTN: Simona F. Krant PHONE NO : 972 9 9551344
6 Hagavish Street SE DECISION MADE: 15-JUL-20
Neanya IL 4250706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VibrantVue Scleral Saline
Dry Eye Innovations, LLC 510(k) NO: K201069(Traditional)
ATTN: Donald R. Sanders PHONE NO : 630 5309700
1200 Harger Rd. Suite 211 SE DECISION MADE: 31-JUL-20
Oak Brook IL 60523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
Visco Vision Inc 510(k) NO: K201080(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 15-JUL-20
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
Parcus Medical, LLC 510(k) NO: K201083(Traditional)
ATTN: Paul Vagts PHONE NO : 1 941 7557965
6423 Parkland Dr SE DECISION MADE: 23-JUL-20
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORBEL Spacers
Globus Medical, Inc. 510(k) NO: K201087(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
Valley Forge Business Center 2560 SE DECISION MADE: 31-JUL-20
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu Duodeno System
Ambu Innovation GmbH 510(k) NO: K201098(Traditional)
ATTN: Oliver V Ruepprecht PHONE NO : 49 8233 2189028
Peterhofstr 3b SE DECISION MADE: 17-JUL-20
Kissing DE 86438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser Therapy System
Shanghai Apolo Medical Technology 510(k) NO: K201109(Traditional)
ATTN: Felix Li PHONE NO : 86 138 49190618
4F, Building A, No.388, Yindu RoadSE DECISION MADE: 15-JUL-20
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Canon non-mydriatic retinal camera CR series
Canon Inc. 510(k) NO: K201122(Special)
ATTN: Akira Hirai PHONE NO : 011 81 337582111
9-1, Imaikami-cho SE DECISION MADE: 23-JUL-20
Nakahara-ku, Kawasaki JP 211-8501510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Compression Screws
Arthrex Inc. 510(k) NO: K201132(Traditional)
ATTN: Samantha Passman PHONE NO : 1 239 6435553 71595
1370 Creekside Boulevard SE DECISION MADE: 27-JUL-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink Plating System
In2Bones USA, LLC 510(k) NO: K201149(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 15-JUL-20
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode RF Multi-System
InMode Ltd. 510(k) NO: K201150(Traditional)
ATTN: Amit Goren PHONE NO : 972 4909 7470
Tabor Building, Shaar Yokneam SE DECISION MADE: 22-JUL-20
Yokneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Covidien llc 510(k) NO: K201179(Traditional)
ATTN: Ligia Mastronardi PHONE NO : 303 9127752
6135 Gunbarrel Avenue SE DECISION MADE: 20-JUL-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KY Grosz Jelly
RB Health (US) LLC 510(k) NO: K201186(Traditional)
ATTN: Elizabeth Viguerie PHONE NO : 973 4042715
399 Interpace Pkwy SE DECISION MADE: 30-JUL-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
Smith & Nephew 510(k) NO: K201198(Traditional)
ATTN: Janice Haselton PHONE NO : 978 7491494
150 Minuteman Rd SE DECISION MADE: 17-JUL-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visera Elite II Video System Center
Olympus Medical Systems Corp. 510(k) NO: K201200(Special)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 22-JUL-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPERE Thrombectomy System
Vascular Medcure, Inc. 510(k) NO: K201216(Special)
ATTN: Jeffrey P. DuMontelle PHONE NO : 714 9150886
1500 S. Sunkist St. - Suite H SE DECISION MADE: 08-JUL-20
Anaheim CA 92806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc. 510(k) NO: K201227(Special)
ATTN: Haylie Hertz PHONE NO : 855 7862828
14445 Grasslands Dr. SE DECISION MADE: 17-JUL-20
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD SoloShot Mini Syringe/ BD Auto Disable Syringe
Becton, Dickinson, and Company 510(k) NO: K201234(Traditional)
ATTN: Avital Merl PHONE NO : 201 8474739
1 Becton Drive SE DECISION MADE: 15-JUL-20
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex MaxForce MTP Compression Plates and Screws
Arthrex Inc. 510(k) NO: K201235(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 06-JUL-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Specimen Retrieval Bag
Beijing Biosis Healing Biological 510(k) NO: K201243(Traditional)
ATTN: Jiali Zhou PHONE NO : 86 10 61252600
No.6 plant west, Valley No.1 Bio-mSE DECISION MADE: 10-JUL-20
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geneva
Nucletron BV 510(k) NO: K201272(Traditional)
ATTN: Rigo Meens PHONE NO : 31 318 557133
Waardgelder 1 SE DECISION MADE: 16-JUL-20
Veenendaal NL 3905TH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExacTrac Dynamic
Brainlab AG 510(k) NO: K201276(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 13-JUL-20
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSISTO Universal Applicator Clamping Device
Geomed Medizin-Technik GmbH & Co. 510(k) NO: K201279(Traditional)
ATTN: Hanno Haug PHONE NO : 49 746 193550
Ludwigstaler Strasse 27 SE DECISION MADE: 10-JUL-20
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
Ethicon Endo-Surgery LLC 510(k) NO: K201280(Special)
ATTN: Nathan Anderson PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 27-JUL-20
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ureterorenoscope System
Shanghai AnQing Medical Instrument510(k) NO: K201293(Special)
ATTN: Shuwen Fan PHONE NO : 86 02161 117375
3rd & 4th Floor, No.2 Building, 36SE DECISION MADE: 24-JUL-20
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-Rapha Solution
IRM Inc 510(k) NO: K201296(Traditional)
ATTN: Kim Yun Ik PHONE NO : 82 70 82306690
4th-D, Myung-Woo Bldg, 169, YeoksaSE DECISION MADE: 09-JUL-20
Gangnam-gu KR 06247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD Steth
HD Medical, Inc. 510(k) NO: K201299(Third Party - Traditional)
ATTN: Stephanie Anderson PHONE NO : 408 3386244
3561 Homestead Road #146 SE DECISION MADE: 10-JUL-20
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VisCalor
VOCO GmbH 510(k) NO: K201307(Special)
ATTN: M. Th. Plaumann PHONE NO : 49 4721 7190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 08-JUL-20
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: DePuy Synthes 2.7mm VA LCP Clavicle Plate System
DePuy Synthes 510(k) NO: K201321(Traditional)
ATTN: Stacey Bonnell PHONE NO : 484 2387519
1301 Goshen Parkway SE DECISION MADE: 24-JUL-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allograft MIS Delivery System
LifeNet Health 510(k) NO: K201338(Traditional)
ATTN: Brittany Beasley PHONE NO : 757 6094201
1864 Concert Drive SE DECISION MADE: 13-JUL-20
Virginia Beach VA 23453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon Total KneeSystem
Howmedica Osteonics Corp. dba Stry510(k) NO: K201343(Traditional)
ATTN: Shikha Khandelwal PHONE NO : 201 8316921
325 Corporate Drive SE DECISION MADE: 10-JUL-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith+Nephew Arthroscopes
Smith & Nephew 510(k) NO: K201349(Traditional)
ATTN: Katheen Solomon PHONE NO : 978 7491605
150 Minuteman Rd SE DECISION MADE: 20-JUL-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endomat Select, IBS Shaver Software, License
Karl Storz SE & Co. KG 510(k) NO: K201355(Special)
ATTN: Alexey Davidov PHONE NO : 49 07461 7087909
Dr.-Karl-Storz-Strasse 34 SE DECISION MADE: 22-JUL-20
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PNEUMOCLEAR
W.O.M. WORLD OF MEDICINE GmbH 510(k) NO: K201361(Traditional)
ATTN: Soeren Markworth PHONE NO : 0049 303 9981594
Salzufer 8 SE DECISION MADE: 29-JUL-20
Berlin DE 10587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK TrabecuLink Femoral Cones
Waldemar Link GmbH & Co. KG 510(k) NO: K201364(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53995530
Ostsraße 4-10 SE DECISION MADE: 17-JUL-20
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True 3D Viewer
EchoPixel, Inc. 510(k) NO: K201365(Traditional)
ATTN: Michael Gabler PHONE NO : 844 2737766
4677 Old Ironsides Drive, Suite 44SE DECISION MADE: 17-JUL-20
Santa Clara CA 95054 510(k) STATEMENT
DEVICE: Resoundant Acoustic Driver System
Resoundant Inc 510(k) NO: K201389(Traditional)
ATTN: John Hartigan PHONE NO : 507 3220011
421 First Ave SW Suite 204W SE DECISION MADE: 10-JUL-20
Rochester MN 55902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Picowon
WON TECH Co., Ltd. 510(k) NO: K201406(Traditional)
ATTN: Jake Yu PHONE NO : 82 70 78366921
64 Techno 8-Ro, Yuseong-gu SE DECISION MADE: 22-JUL-20
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Connected OR Hub with Voice Control, Connected OR Hub with Device Control
Stryker 510(k) NO: K201434(Traditional)
ATTN: Meagan Jones PHONE NO : 214 7012186
5900 Optical Court SE DECISION MADE: 28-JUL-20
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Diatron Group 510(k) NO: K201442(Traditional)
ATTN: Frank Matuszak PHONE NO : 732 6789694
12601 N.W. 115th Avenue, Suite A11SE DECISION MADE: 31-JUL-20
Medley FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
Medtronic, Inc. 510(k) NO: K201449(Special)
ATTN: Lisa Corbin PHONE NO : 949 3991670
1851 E. Deere Ave. SE DECISION MADE: 01-JUL-20
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuRgical Planner (SRP) BrainStorm
Surgical Theater, Inc. 510(k) NO: K201465(Traditional)
ATTN: Kevin Murrock PHONE NO : 216 9163806
781 Beta Drive SE DECISION MADE: 17-JUL-20
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via View&GO
Siemens Healthcare GmbH 510(k) NO: K201477(Special)
ATTN: Elango Alampalayam RangappanPHONE NO : 49 9191 184429
Siemensstr. 1 SE DECISION MADE: 01-JUL-20
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DemeMASK
DemeTECH Corporation 510(k) NO: K201479(Abbreviated)
ATTN: Tracy Chadwrick PHONE NO : 305 8241048
14175 NW 60th Avenue SE DECISION MADE: 24-JUL-20
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Traxcess 7 Mini Guidewire
Micro Vention Inc. 510(k) NO: K201487(Special)
ATTN: Ganesh Balachandar PHONE NO : 714 2478000
35 Enterprise SE DECISION MADE: 02-JUL-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rover
Micro-X Ltd. 510(k) NO: K201488(Abbreviated)
ATTN: Mark Norman PHONE NO : 61 8 70993966
A14 6 MAB Eastern Promenade, SE DECISION MADE: 17-JUL-20
Tonsley (Clovelly Park) AU 5042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Endoscopic Trocars and Sleeves
Stryker Sustainability Solutions 510(k) NO: K201511(Traditional)
ATTN: Ramona Kulik PHONE NO : 888 8883433
1810 W. Drake Drive SE DECISION MADE: 31-JUL-20
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
Smith & Nephew, Inc. 510(k) NO: K201527(Traditional)
ATTN: Kayla Franklin PHONE NO : 901 3252471
7135 Goodlett Farms Parkway SE DECISION MADE: 22-JUL-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR570
Shanghai United Imaging Healthcare510(k) NO: K201540(Special)
ATTN: Xin GAO PHONE NO : 86 021 67076888 5386
NO.2258 Chengbei Road, SE DECISION MADE: 06-JUL-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Eclipse Shoulder Prosthesis System
Arthrex, Inc. 510(k) NO: K201542(Special)
ATTN: David L Rogers PHONE NO : 1 239 6435553
1370 Creekside Boulevard SE DECISION MADE: 08-JUL-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGEC® System
NuVasive Specialized Orthopedics, 510(k) NO: K201543(Traditional)
ATTN: Ivanna Lopez PHONE NO : 858 9091878
101 Enterprise, Suite 100 SE DECISION MADE: 30-JUL-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intraosseous Fixation System
Extremity Medical, LLC. 510(k) NO: K201556(Special)
ATTN: Mary Hoffman PHONE NO : 973 5888980
300 Interpace Parkway, Suite 410 SE DECISION MADE: 08-JUL-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIV.A.C. Negative Pressure Wound Therapy System
KCI USA, Inc 510(k) NO: K201571(Special)
ATTN: Jesus Valencia PHONE NO : 210 5154012
6203 Farinon Drive SE DECISION MADE: 08-JUL-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMDR 2C (Multiple Models)
MinXray, Inc 510(k) NO: K201575(Special)
ATTN: Keith Kretchmer PHONE NO : 847 5640323
3611 Commercial Ave SE DECISION MADE: 08-JUL-20
Northbrook IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XACT Robotic System
XACT Robotics Ltd. 510(k) NO: K201586(Special)
ATTN: Chen Levin PHONE NO : 972 4 7700369
8 Hatochen Street, PO Box 3097 SE DECISION MADE: 09-JUL-20
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Looking Glass 4K Integrated Visualization System
ConMed Corporation 510(k) NO: K201593(Special)
ATTN: Kavita Amin PHONE NO : 508 9482084
525 French Road SE DECISION MADE: 08-JUL-20
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liver Incytes, Model 1005
Sonic Incytes 510(k) NO: K201597(Traditional)
ATTN: George Aliphtiras PHONE NO :
560-828 West 10th Ave SE DECISION MADE: 31-JUL-20
Vancouver CA v5z 1m9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
Shenzhen Beacon Display Technology510(k) NO: K201599(Traditional)
ATTN: Fu Ailing PHONE NO : 86 0755 36868363 5150
12F, Block Bl, NanshanZhiyuan, No.SE DECISION MADE: 02-JUL-20
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage
EIT Emerging Implant Technologies 510(k) NO: K201605(Special)
ATTN: Barbara Wirth PHONE NO : 49 7461 1716904
Eisenbahnstrasse 84 SE DECISION MADE: 15-JUL-20
Wurmlingen DE 78573 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse Treatment Planning System v16.1
Varian Medical Systems, Inc 510(k) NO: K201607(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 10-JUL-20
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
Innovasis, Inc. 510(k) NO: K201614(Special)
ATTN: Marshall McCarty PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 15-JUL-20
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyMRI
SyntheticMR AB 510(k) NO: K201616(Traditional)
ATTN: Raymond Kelly PHONE NO : 203 4007566
Storgatan 11 SE DECISION MADE: 28-JUL-20
Linkoping SE SE-582 23 510(k) STATEMENT
DEVICE: Nalu Neurostimulation SCS system
Nalu Medical, Inc 510(k) NO: K201618(Special)
ATTN: Michele Chin-Purcell PHONE NO : 760 4482360
2320 Faraday Ave. Suite 100 SE DECISION MADE: 15-JUL-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magicore II System
InnoBioSurg Co., Ltd. 510(k) NO: K201621(Special)
ATTN: Bo-Yeon Lim PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 15-JUL-20
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terason uSmart 3200T Plus Ultrasound System
Teratech Corporation 510(k) NO: K201633(Third Party - Traditional)
ATTN: Benjamin Chiampa PHONE NO : 781 2704143
77-79 Terrace Hall Ave. SE DECISION MADE: 02-JUL-20
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DuraDiagnost
Philips Healthcare (Suzhou) Co., L510(k) NO: K201640(Special)
ATTN: Mary Zhu PHONE NO : 86 021 24128746
No. 258, Zhong Yuan Road, Suzhou ISE DECISION MADE: 09-JUL-20
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterispine™ PS
Safe Orthopaedics 510(k) NO: K201648(Traditional)
ATTN: Pierre Dumouchel PHONE NO : 33 0184 280179
Parc des Bellevues, Allee R. LuxemSE DECISION MADE: 30-JUL-20
Eragny Sur Oise FR 95610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Kyocera Medical Technologies, Inc.510(k) NO: K201660(Special)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1200 California St. Suite 210 SE DECISION MADE: 16-JUL-20
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDUCT® Headless Compression Screw System
Skeletal Dynamics, Inc. 510(k) NO: K201662(Special)
ATTN: Diana Taylor PHONE NO : 305 5967585 7215
7300 N. Kendall Drive, Suite 400 SE DECISION MADE: 16-JUL-20
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Lumenis Ltd. 510(k) NO: K201663(Special)
ATTN: Shlomit Segman PHONE NO : 972 2 9599230
6 Hakidma Street PO Box 240 SE DECISION MADE: 16-JUL-20
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signia Stapler (with new software)
Covidien 510(k) NO: K201672(Special)
ATTN: Katherine Y Choi PHONE NO : 917 8416315
60 Middletown Avenue SE DECISION MADE: 17-JUL-20
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barricaid Instrument Tray
Intrinsic Therapeutics, Inc. 510(k) NO: K201676(Special)
ATTN: Regina Shih PHONE NO : 781 9320222
30 Commerce Way SE DECISION MADE: 16-JUL-20
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Riptide Aspiration System
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K201689(Special)
ATTN: Kristy Ann Darling PHONE NO : 949 4903819
9775 Toledo Way SE DECISION MADE: 21-JUL-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K201690(Special)
ATTN: Prerana Gurubasavaraj PHONE NO : 949 2975804
9775 Toledo Way SE DECISION MADE: 21-JUL-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
Surgical Instrument and Savings In510(k) NO: K201699(Special)
ATTN: Stephanie Boyle Mays PHONE NO : 541 9233375
1500 NE Hemlock Ave SE DECISION MADE: 22-JUL-20
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVVIGO Guidance System
Boston Scientific Corporation 510(k) NO: K201713(Special)
ATTN: Kevin Catalano PHONE NO : 763 4942413
Three Scimed Place SE DECISION MADE: 23-JUL-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigitalDiagnost C50
Philips Healthcare (Suzhou) Co., L510(k) NO: K201725(Special)
ATTN: Claire Zhang PHONE NO : 86 2124 128746
No. 258, ZhongYuan Road Suzhou IndSE DECISION MADE: 10-JUL-20
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pedicle Screw System
Black Box Medical LLC 510(k) NO: K201751(Special)
ATTN: Todd Stanaford PHONE NO : 432 3129977
4516 East County Road 45 SE DECISION MADE: 22-JUL-20
Midland TX 79705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zoom 14 Guidewire
Scientia Vascular LLC 510(k) NO: K201760(Special)
ATTN: Amy McManus PHONE NO : 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 29-JUL-20
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True Tulip System, True M.I.S. System
Innovative Surgical Designs, Inc. 510(k) NO: K201780(Special)
ATTN: Jon Rinehart PHONE NO : 217 8368522 103
3903 S. Walnut St. SE DECISION MADE: 22-JUL-20
Bloomington IN 47401 510(k) STATEMENT
DEVICE: Arthrex Mini Hip PushLock
Arthrex Inc. 510(k) NO: K201786(Special)
ATTN: Kelsey Roberts PHONE NO : 1 239 5984302 72257
1370 Creekside Boulevard SE DECISION MADE: 30-JUL-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUSELECT Microcatheter
Boston Scientific Corporation 510(k) NO: K201792(Special)
ATTN: Aoife Tobin PHONE NO : 763 9558049
3 Scimed Place SE DECISION MADE: 28-JUL-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jade
OrbusNeich Medical (Shenzhen) Co.,510(k) NO: K201794(Special)
ATTN: Daniel Zhang PHONE NO : 86 75583 580181
No.1st Jinkui Road Futian Free TraSE DECISION MADE: 28-JUL-20
Shenzhen CN 518038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1717SCV, 1717SGV
Rayence Co., Ltd. 510(k) NO: K201796(Special)
ATTN: Kee Dock Kim PHONE NO :
14, Samsung 1-ro 1-gil SE DECISION MADE: 23-JUL-20
Hwaseong-si KP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: myQA iON
IBA Dosimetry GmbH 510(k) NO: K201798(Third Party - Traditional)
ATTN: Andreas Suchi PHONE NO : 49 9128 607943
Bahnhofstrasse 5 SE DECISION MADE: 17-JUL-20
Schwarzenbruck DE D-90592 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
BiPad Surgical, Inc. 510(k) NO: K201833(Third Party - Traditional)
ATTN: Louis Cornacchia PHONE NO : 888 6356381
110 Ocean Blvd SE DECISION MADE: 31-JUL-20
Point Lookout NY 11569 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HI-TORQUE PROCEED Guide Wire Family
Abbott Vascular 510(k) NO: K201834(Special)
ATTN: Charlotte Pullman PHONE NO : 408 8450652
3200 Lakeside Drive SE DECISION MADE: 30-JUL-20
Santa Clara CA 95094 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
NeoTract, Inc. 510(k) NO: K201837(Special)
ATTN: Brian Gall PHONE NO : 925 3296547
4155 Hopyard Road SE DECISION MADE: 31-JUL-20
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
Corentec Co., Ltd 510(k) NO: K201851(Special)
ATTN: Sungwon Yang PHONE NO : 82 41 5857144
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 30-JUL-20
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Guide SCENERGY
Clear Guide Medical 510(k) NO: K201898(Traditional)
ATTN: Jack Kent PHONE NO : 410 2151638
3600 Clipper Mill Rd., Suite 400 SE DECISION MADE: 31-JUL-20
Baltimore MD 21211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cemented Origin Hip Stem
Signature Orthopaedics Pty Ltd. 510(k) NO: K201951(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2942 85181
7 Sirius Road SE DECISION MADE: 31-JUL-20
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 252
TOTAL WITH SUMMARIES 241
TOTAL WITH STATEMENTS 11
