510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2021
DEVICE: Acuitas AMR Gene Panel
OpGen, Inc. 510(k) NO: K191288(Traditional)
ATTN: Autumn Collasius PHONE NO : 301 8699683
9717 Key West Avenue Suite 100 SE DECISION MADE: 30-SEP-21
Rockville MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Ferritin
DiaSorin Inc 510(k) NO: K193650(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Ave SE DECISION MADE: 14-SEP-21
Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Wheelchair (XW-LY001)
Yongkang Dingchang Industry & Trad510(k) NO: K200423(Traditional)
ATTN: Tony Chen PHONE NO : 86 134 29055889
NO.99 Huaxi road, Xicheng street SE DECISION MADE: 22-SEP-21
Yongkang CN 321300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP-iX
Sejong Medical Co., Ltd. 510(k) NO: K200639(Traditional)
ATTN: Yoojung Choi PHONE NO :
11, Sinchon 2-ro SE DECISION MADE: 29-SEP-21
Paju-si CN 10880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Medicon Hellas, S.A 510(k) NO: K200898(Traditional)
ATTN: Frank Matuszak PHONE NO : 302 1 06606000
Melitona 5-7 SE DECISION MADE: 21-SEP-21
Gerakas GR 15344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYMAX Tag Self-Monitoring Blood Glucose System
EPS Bio Technology Corp. 510(k) NO: K201258(Special)
ATTN: Iden Chen PHONE NO : 886 36686 868
No. 8 R&D RD.III Hsinchu Science PSE DECISION MADE: 01-SEP-21
Hsinchu City TW 30077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
Atrium Medical Corporation 510(k) NO: K201305(Traditional)
ATTN: Robin Mulvey PHONE NO : 603 8645352
40 Continental Blvd. SE DECISION MADE: 03-SEP-21
Merrimack NH 03054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Troponin T Gen 5
Roche Diagnostics 510(k) NO: K201441(Traditional)
ATTN: Jane Phillips PHONE NO : 317 5213338
9115 Hague Road SE DECISION MADE: 21-SEP-21
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MultiCath, AcQRate Dx Fixed Curve Catheter
Biotronik, Inc 510(k) NO: K201445(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 02-SEP-21
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Cardinal Health 200, LLC 510(k) NO: K201592(Traditional)
ATTN: Padmini Sahoo PHONE NO : 847 7854959
3651 Birchwood Drive SE DECISION MADE: 26-SEP-21
Waukegan IL 60085 510(k) STATEMENT
DEVICE: Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
Viramal Limited 510(k) NO: K201612(Traditional)
ATTN: Simona Fiore PHONE NO : 44 0207 4953052
106 New Bond Street SE DECISION MADE: 02-SEP-21
London GB W1S 1DN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIEN Dental Cleanser
EPIEN Medical, Inc. 510(k) NO: K201785(Traditional)
ATTN: Reginald Dupre PHONE NO : 651 6533380
4225 White Bear Parkway Suite 600 SE DECISION MADE: 09-SEP-21
St. Paul MN 55110 510(k) STATEMENT
DEVICE: CT-STOR
Energy Delivery Solutions 510(k) NO: K201789(Traditional)
ATTN: William Ehringer PHONE NO : 812 9200596
3315 Industrial Parkway SE DECISION MADE: 20-SEP-21
Jeffersonville IN 47130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDEN Peek Cage
JMT Co., Ltd 510(k) NO: K201793(Traditional)
ATTN: Sang-Ok Nam PHONE NO : 82 31 8680951
70-39, Gwonyul-ro 1203 beon-gile, SE DECISION MADE: 13-SEP-21
Yangju-si KR 11517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
Olympus Medical Systems Corp. 510(k) NO: K201832(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 17-SEP-21
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrically Powered Wheelchair -Model HP358E
Kunshan Hi-Fortune Health Products510(k) NO: K201855(Traditional)
ATTN: Jianjiang Fan PHONE NO : 86 512 55195100
No. 625, Juxiang Road, Zhangpu TowSE DECISION MADE: 28-SEP-21
Kunshan CN 215321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Applied Medical Resources Corporat510(k) NO: K202049(Special)
ATTN: Andrew Powers Davis PHONE NO : 949 5474136
22872 Avenida Empresa SE DECISION MADE: 07-SEP-21
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kinepict Medical Imaging Tool 4.0
Kinepict Health Ltd 510(k) NO: K202056(Traditional)
ATTN: Lilla Strobel PHONE NO : 36 317 852260
Kelta k z SE DECISION MADE: 10-SEP-21
Budakeszi HU 2092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABC Dental Implant System
Abracadabra Implants Ltd 510(k) NO: K202092(Traditional)
ATTN: Daniel Younisian PHONE NO : 972 54 4778556
12 Hacharoshet St SE DECISION MADE: 23-SEP-21
Or Yehuda IL 6037580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tracheal Stent System
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K202204(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No.10 Gaoke Third Road SE DECISION MADE: 01-SEP-21
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RXS 1000
Rolence Enterprise Inc. 510(k) NO: K202369(Traditional)
ATTN: Ben Chang PHONE NO : 886 3 4631999
18-3 Lane 231 Pu Chung Rd., ChunglSE DECISION MADE: 15-SEP-21
Taoyuan TW 32083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP-1000, SP-2000
DaeSung Maref Co., Ltd 510(k) NO: K202395(Traditional)
ATTN: Hyoung Ju Cho PHONE NO : 82 31 4597211
298-24, Gongdan-ro SE DECISION MADE: 01-SEP-21
Gunpo-si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
bioMerieux, Inc. 510(k) NO: K202396(Traditional)
ATTN: Debra Broyles PHONE NO : 314 7318805
595 Anglum Road SE DECISION MADE: 14-SEP-21
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
Pharma System AB 510(k) NO: K202459(Traditional)
ATTN: Viljar Salumaa PHONE NO : 46 18 349500
Rubanksgatan 9 SE DECISION MADE: 26-SEP-21
Knivsta SE 74171 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermArt (Model IR-EFT)
Comper Chuangxiang (Beijing) techn510(k) NO: K202481(Traditional)
ATTN: Han Du PHONE NO : 86 10 57480968
Building 1, Unit 4, Room 102, 103 SE DECISION MADE: 28-SEP-21
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA Rib-P
Phadia AB 510(k) NO: K202540(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 13-SEP-21
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA RNA Pol III
Phadia AB 510(k) NO: K202541(Traditional)
ATTN: Sheryl Skinner PHONE NO : 269 5683603
Rapsgatan 7P P.O. Box 6460 SE DECISION MADE: 13-SEP-21
Uppsala SE 751 37 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IV Administration Sets
B. Braun Medical Inc. 510(k) NO: K202618(Traditional)
ATTN: Kimberly Smith PHONE NO : 610 2660500
901 Marcon Blvd. SE DECISION MADE: 24-SEP-21
Allentown PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentilube Spray
Oxy2plus, LLC 510(k) NO: K202689(Traditional)
ATTN: Chun nan Lin PHONE NO : 626 8728550
4120 Rosemead Blvd SE DECISION MADE: 03-SEP-21
Rosemead CA 91770 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Low-speed Handpieces and Accessories
MicroP Technology (Taiwan), Inc. 510(k) NO: K202786(Traditional)
ATTN: Ina Lin PHONE NO : 886 527 68238
No.50, Zhongxiao 2nd St., East DisSE DECISION MADE: 03-SEP-21
Chiayi City TW 600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntec Orthodontic Mini Screw Extended System
Syntec Scientific Corporation 510(k) NO: K202790(Special)
ATTN: Nicole Tseng PHONE NO : 886 4 7987099
No.2, Kung San Road Chuan Shing InSE DECISION MADE: 17-SEP-21
Chang Hua TW 50971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANSIN Tubing Sets for Hemodialysis
Jiangxi Sanxin Medtec Co., Ltd. 510(k) NO: K202796(Traditional)
ATTN: Shuiqing Sun PHONE NO : 86 791 85950238
No. 999, Fushan Road, Xiaolan EconSE DECISION MADE: 06-SEP-21
Nanchang CN 330200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlucoSure HT Plus Blood Glucose Monitoring System
Apex BioTechnology Corp. 510(k) NO: K202885(Special)
ATTN: Lisa Liu PHONE NO : 011 886 35641952
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 15-SEP-21
Hsinchu CN 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoLIF Delta-Cage and DoubleWedge-Cage
joimax GmbH 510(k) NO: K203014(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
Amalienbadstrasse 41 SE DECISION MADE: 01-SEP-21
RaumFabrik 61 DE 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Medtronic 510(k) NO: K203111(Traditional)
ATTN: Kaitlin Cady PHONE NO : 763 2918500
7611 Northland Drive SE DECISION MADE: 16-SEP-21
Minneapolis MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Yangzhou Runyi Arts & Crafts CO., 510(k) NO: K203112(Traditional)
ATTN: Li Yu PHONE NO : 086 0514 82082789
4. NO.87 West Heye Road HanJiang DSE DECISION MADE: 16-SEP-21
Yangzhou CN 225008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uramix CuraWay Biopsy Needle
Uramix, Inc. 510(k) NO: K203141(Traditional)
ATTN: Michael Mooreville PHONE NO : 1 610 3949850
272 N. Lansdowne Ave. SE DECISION MADE: 17-SEP-21
Lansdowne PA 19050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreatheSuite MDI V1
BreatheSuite Inc 510(k) NO: K203155(Traditional)
ATTN: Brett Vokey PHONE NO : 709 7651002
29 Rowan Street Unit 2 SE DECISION MADE: 17-SEP-21
St. John's CA A1B2X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOtube
Nissha Medical Technologies SAS 510(k) NO: K203350(Traditional)
ATTN: Roch Mignot PHONE NO : 00 33 139721177
ZA Des Boutries 12 Rue Des CayenneSE DECISION MADE: 29-SEP-21
Conflans STE Honorine FR 78700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
Ningbo Ouhan Medical Device Co., L510(k) NO: K203418(Traditional)
ATTN: Annie Annie PHONE NO : 86 574 62137999
No.16, West Ruhu Road, Simen Town SE DECISION MADE: 17-SEP-21
Yuyao City CN 315470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BlueStar Rx
WellDoc, Inc 510(k) NO: K203434(Traditional)
ATTN: Sabyasachi Roy PHONE NO : 443 6923100
10221 Wincopin Circle, Suite 150 SE DECISION MADE: 08-SEP-21
Columbia MD 21044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TorrentX Wound Wash
Next Science, LLC 510(k) NO: K203446(Traditional)
ATTN: Courtney Narain PHONE NO : 855 5642762
10550 Deerwood Park Blvd Ste 300 SE DECISION MADE: 23-SEP-21
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Fujian Kang Chen Daily Necessities510(k) NO: K203455(Traditional)
ATTN: Shuyan Wang PHONE NO : 86 595 28892058
No.55 Houdun Road, houmao IndustriSE DECISION MADE: 13-SEP-21
Quanzhou CN 362000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instrument tray, for semi-rigid ureteroscope
Olympus Winter & Ibe GmbH 510(k) NO: K203492(Traditional)
ATTN: Jan-Oliver Upmeier PHONE NO : 49 40 669662098
Kuehnstr, 61 SE DECISION MADE: 15-SEP-21
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Male Latex Condom
Global Protection Corp. 510(k) NO: K203536(Abbreviated)
ATTN: Christina Cataldo PHONE NO : 617 9462800
12 Channel Street SE DECISION MADE: 03-SEP-21
Boston MA 02210 510(k) STATEMENT
DEVICE: AmCAD-UT
AmCad BioMed Corporation 510(k) NO: K203555(Traditional)
ATTN: Nathan Liu PHONE NO : 866 2 27136227
FL. 5-2, No.167, Fu Hsing N. RD. SE DECISION MADE: 08-SEP-21
Taipei TW 105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intravascular Administration Sets
Baxter Healthcare Corporation 510(k) NO: K203609(Traditional)
ATTN: Jeffrey E. Thompson PHONE NO : 224 2703806
25212 West Illinois Route 120 SE DECISION MADE: 30-SEP-21
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Numen Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co.510(k) NO: K203625(Traditional)
ATTN: Qiuhua Zou PHONE NO : 86 21 38954600 3959
16th Building, 222 Guangdan Road, SE DECISION MADE: 01-SEP-21
Shanghai CN 201318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruAbutment DS, TruBase
TruAbutment Inc. 510(k) NO: K203649(Traditional)
ATTN: Eunjin Jang PHONE NO : 714 9561488
17666 Fitch SE DECISION MADE: 15-SEP-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
Yibin Junxin Electronics Technolog510(k) NO: K203662(Traditional)
ATTN: Chaoze Guan PHONE NO : 86 135 30731921
Building B2, No. 136, West SectionSE DECISION MADE: 23-SEP-21
Yibin CN 644000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
MYCO Medical Supplies, Inc. 510(k) NO: K203668(Traditional)
ATTN: Sanjiv Krumar PHONE NO : 919 4602535
2015 Production Drive SE DECISION MADE: 29-SEP-21
Apex NC 27539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B Dispensing Line
AEA srl 510(k) NO: K203674(Traditional)
ATTN: Michele Mengoni PHONE NO : 003 907 31816689
Via Fiume 16 SE DECISION MADE: 27-SEP-21
Angeli de Rosora IT 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayPilot System
Micropos Medical AB 510(k) NO: K203722(Traditional)
ATTN: Thomas Lindstrom PHONE NO : 46 31 7608005
Adolf Edelsvards gata 11 SE DECISION MADE: 02-SEP-21
Gothenburg SE SE414 51 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DT100 Digital Thermometer
Smart Technology Co., Ltd. 510(k) NO: K203731(Traditional)
ATTN: Meg Mei PHONE NO : 086 020 62321333
No. 8 Xingcheng East Road, Fuwan ISE DECISION MADE: 26-SEP-21
Foshan CN 528500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
Covidien 510(k) NO: K203762(Traditional)
ATTN: Ashley Johnston PHONE NO : 720 4401057
6135 Gunbarrel Ave SE DECISION MADE: 17-SEP-21
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClariSIGMAM
ClariPi Inc. 510(k) NO: K203785(Traditional)
ATTN: Hyun-Sook Park PHONE NO : 82 8 7413014
3F, 70-15, Ihwajang-gil SE DECISION MADE: 10-SEP-21
Seoul KR 03088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProFlex CO2 Laser Fiber
InnovaQuartz LLC 510(k) NO: K203799(Traditional)
ATTN: Stephen Griffin PHONE NO : 623 4341895 101
23030 N. 15th Ave SE DECISION MADE: 20-SEP-21
Phoenix AZ 85027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips IntelliSite Pathology Solution
Philips Medical Systems Nederland 510(k) NO: K203845(Abbreviated)
ATTN: Liselotte Kornmann PHONE NO : 31 611 621238
Veenpluis 6 SE DECISION MADE: 17-SEP-21
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
Leadtek Research Inc. 510(k) NO: K210032(Special)
ATTN: Kun-Shan Lu PHONE NO : 886 2 82265800
18F, No. 166, Jian-Yi Rd., Chung HSE DECISION MADE: 01-SEP-21
New Taipei City TW 23511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVA PRESTO PACK
Pulpdent Corporation 510(k) NO: K210045(Traditional)
ATTN: Lewis Berk PHONE NO : 617 9266666
80 Oakland Street SE DECISION MADE: 22-SEP-21
Watertown MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HealthCCSng
Zebra Medical Vision Ltd. 510(k) NO: K210085(Traditional)
ATTN: Shlomit Cymbalista PHONE NO : 972 52 2574837
Shefayim Commercial Center, PO BoxSE DECISION MADE: 15-SEP-21
Shefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuFFRangio
ArteryFlow Technology Co., Ltd. 510(k) NO: K210093(Traditional)
ATTN: Jianping Xiang PHONE NO : 86 571 86772567
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 10-SEP-21
Hangzhou CN 310051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRARED BODY THERMOMETER (Model: YK-001)
Longnan RenZhong Medical Equipment510(k) NO: K210118(Traditional)
ATTN: Liangping Liao PHONE NO : 86 13 715212441
Information Industry Technology CiSE DECISION MADE: 15-SEP-21
Ganzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Current Health Monitoring System Gen 2 (G2)
Current Health 510(k) NO: K210133(Traditional)
ATTN: Phil Bromley PHONE NO : 44 131 2858101
Playfair House, 6 Broughton StreetSE DECISION MADE: 03-SEP-21
Edinburgh GB EH 1 3LY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Digital Blood Pressure Monitor
AVICHE Shandong Medical Technology510(k) NO: K210152(Traditional)
ATTN: Zhike Song PHONE NO : 86 15 689734848
Floor 26, Building A, A2-1 Jinan PSE DECISION MADE: 23-SEP-21
Jinan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlertWatch:AC
AlertWatch, Inc. 510(k) NO: K210160(Traditional)
ATTN: Justin Adams PHONE NO : 734 9988344
330 East Liberty St., Fourth FloorSE DECISION MADE: 10-SEP-21
Ann Arbor MI 48104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wilson Tech Disposable Medical Face Mask
Wilson Tech (International) Limite510(k) NO: K210184(Traditional)
ATTN: Ho Hang Terry Ting PHONE NO : 852 231 25136
RM B, 7 Floor Joy Fat Factory BuilSE DECISION MADE: 14-SEP-21
Kowloon HK 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile syringe for single use with/without needle
Zhejiang Kangkang Medical-Devices 510(k) NO: K210227(Traditional)
ATTN: Chun Guo PHONE NO : 1358 6180908
Longwang Industrial District, ChumSE DECISION MADE: 10-SEP-21
Yuhuan CN 317605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Needles for Single Use
Zhejiang Kangkang Medical-Devices 510(k) NO: K210232(Traditional)
ATTN: Chun Guo PHONE NO :
Longwang Industrial District, ChumSE DECISION MADE: 23-SEP-21
Yuhuan CN 317605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MeMed BV
MeMed Diagnostics Ltd. 510(k) NO: K210254(Traditional)
ATTN: Efrat Hartog-David PHONE NO : 972 4 8500302
Nahum Heth 5 SE DECISION MADE: 01-SEP-21
Tirat Carmel IL 3508504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mpres Neck Preserving Stem
MEDACTA INTERNATIONAL, SA 510(k) NO: K210263(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91696 6060
Strada Regina SE DECISION MADE: 22-SEP-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: One Touch Spiral Condom
Thai Nippon Rubber Industry Public510(k) NO: K210294(Traditional)
ATTN: Ryosuke Takamiya PHONE NO : 66 38 317999
789/139 Pinthong Industrial EstateSE DECISION MADE: 23-SEP-21
Sriracha TH 20230 510(k) STATEMENT
DEVICE: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
STERIS Corporation 510(k) NO: K210342(Traditional)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Rd SE DECISION MADE: 03-SEP-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas Cdiff nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc. 510(k) NO: K210385(Special)
ATTN: Gaila Balniene PHONE NO : 510 3056980
4300 Hacienda Drive SE DECISION MADE: 09-SEP-21
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harmony Referral System
Topcon Healthcare Solutions EMEA O510(k) NO: K210396(Traditional)
ATTN: Ramya Sundaram PHONE NO : 201 5995553
Makelininkatu 43 SE DECISION MADE: 13-SEP-21
Oulu FI 90100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unifine SafeControl
Owen Mumford Ltd 510(k) NO: K210399(Special)
ATTN: Darren Mansell PHONE NO : 440 1993 812021
Brook Hill SE DECISION MADE: 17-SEP-21
Woodstock GB OX20 1TU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curiteva Sacroiliac Joint Fusion System
Curiteva, Inc. 510(k) NO: K210402(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive SE DECISION MADE: 09-SEP-21
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean Pre-Milled Abutment Mini
Dentis Co., Ltd. 510(k) NO: K210410(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 10-SEP-21
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Versana Premier
GE Medical Systems Ultrasound and 510(k) NO: K210438(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W Innovation Drive SE DECISION MADE: 10-SEP-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sampler Inactivated Transport Media, Nest ITM
Wuxi Nest Biotechnology Co., Ltd. 510(k) NO: K210440(Traditional)
ATTN: Cheng Zhiwei PHONE NO : 86 510 68006788
No. 530 Xida Road, New District SE DECISION MADE: 20-SEP-21
Wuxi CN 214012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Incontinence Probe
Shenzhen Med-link Electronics Tech510(k) NO: K210441(Traditional)
ATTN: Yongfen Yang PHONE NO : 0086 755 61568825 887
4th And 5th Floor, Building Two, HSE DECISION MADE: 17-SEP-21
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: End Cap
Medical Components Inc. (Medcomp) 510(k) NO: K210461(Traditional)
ATTN: Patrick McDonald PHONE NO : 215 8590995
1499 Delp Drive SE DECISION MADE: 14-SEP-21
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-CURVE Interbody Fusion Device
Medicrea International S. A. 510(k) NO: K210470(Traditional)
ATTN: Karine Trogneux PHONE NO : 00 334 72018787
5389 Route De Strasbourg - Vancia SE DECISION MADE: 03-SEP-21
Rillieux-La-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rocket Platinum Cured Cathter
Rocket Medical Plc 510(k) NO: K210509(Traditional)
ATTN: Tracy Charlton PHONE NO : 00 44 1914194488 4067
2-4 Sedling Road SE DECISION MADE: 09-SEP-21
Washington GB NE38 9BZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
Universal Incorporation 510(k) NO: K210513(Traditional)
ATTN: Mei-Hui Huang PHONE NO : 886 2 25119161
10F., No.372 Linsen N. Rd.,ZhongshSE DECISION MADE: 29-SEP-21
Taipei City TW 10446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implanova
Dental Evolutions Inc. 510(k) NO: K210523(Traditional)
ATTN: Matthew Mineros PHONE NO : 310 2732819
9100 Wilshire Blvd Ste 448W SE DECISION MADE: 30-SEP-21
Beverly Hills CA 90212 510(k) STATEMENT
DEVICE: Advisor Pro Platform
DreaMed Diabetes Ltd. 510(k) NO: K210561(Traditional)
ATTN: Inbal Beinglass Peled PHONE NO : 972 52 3642760
5 Mota Gur St. SE DECISION MADE: 28-SEP-21
Petah Tikva IL 4952701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
Cardiovascular Systems Inc. 510(k) NO: K210586(Special)
ATTN: Kris Miller PHONE NO : 612 9993749
1225 Old Highway 8 NW SE DECISION MADE: 14-SEP-21
New Brighton MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axis Spine Technologies ALIF
Axis Spine Technologies Ltd 510(k) NO: K210590(Traditional)
ATTN: Edwin Lindsay PHONE NO : 44 791 7134922
Suite 204, 54-56 Victoria Street, SE DECISION MADE: 29-SEP-21
St. Albans GB AL1 3HZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
FUJIFILM medwork GmbH 510(k) NO: K210625(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
Medworkring 1 SE DECISION MADE: 10-SEP-21
Hochstadt DE 91315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnGuard2 Chemfort Closed Administration (CADM)
Simplivia Healthcare LTD. 510(k) NO: K210707(Traditional)
ATTN: Shay Shaham PHONE NO : 972 4 6908826
North Industrial Zone SE DECISION MADE: 23-SEP-21
Kiryat Shmona IL 1101801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Verifine Mechanical Safety Insulin Syringe
Promisemed Hangzhou Meditech Co., 510(k) NO: K210712(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 08-SEP-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmersiveTouch
ImmersiveTouch, Inc. 510(k) NO: K210726(Traditional)
ATTN: P. Pat Banerjee PHONE NO : 1 630 5705943
910 W Van Buren St, Suite 715 SE DECISION MADE: 29-SEP-21
Chicago IL 60607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inman Digital Clear Aligners
Inman Orthodontic Laboratories, In510(k) NO: K210763(Traditional)
ATTN: Donal P. Inman PHONE NO : 800 2890118
3953 NW 126th Avenue SE DECISION MADE: 29-SEP-21
Coral Springs FL 33065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
VR Vertical LLC dba XRGO 510(k) NO: K210772(Traditional)
ATTN: Matthew DiPalma PHONE NO : 716 6729904
10645 Freeport Drive SE DECISION MADE: 22-SEP-21
Louisville KY 40258 510(k) STATEMENT
DEVICE: TrueCare Biomedix Tamper Evident Cap
US Infusion Inc. D/B/A Truecare Bi510(k) NO: K210818(Traditional)
ATTN: Abbey Kramarz PHONE NO : 866 5938444 206
6356 Manor Ln Ste 101 SE DECISION MADE: 15-SEP-21
South Miami FL 33143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Personal Lubricant
Shenzhen Huanqiu Xuebao Technology510(k) NO: K210857(Traditional)
ATTN: Jiao Li PHONE NO :
Room 303, Building 2, Lane 2, JinjSE DECISION MADE: 24-SEP-21
Bao'an District Shenzhen CN 51810510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker GmbH 510(k) NO: K210861(Traditional)
ATTN: Jonathan Schell PHONE NO : 484 8895804
325 Corporate Drive SE DECISION MADE: 03-SEP-21
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves Powder Free (Blue)
Great Eco Glove Sdn. Bhd. 510(k) NO: K210868(Traditional)
ATTN: Soh Wei Li PHONE NO : 601 62641024
Lot 1675, Jalan Makmur, Batu 28, ISE DECISION MADE: 02-SEP-21
Bestari Jaya MY 45600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (Model: CM2006, CM2008, A88)
Shenzhen RealTone Medical Applianc510(k) NO: K210878(Traditional)
ATTN: Wei Zhou PHONE NO : 86 13 480838587
Flat B, 5 Floor, Yaoxiang IndustriSE DECISION MADE: 28-SEP-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDDHARTH-II; IMPACT
Panacea Medical Technologies Pvt.L510(k) NO: K210894(Traditional)
ATTN: Valli G PHONE NO : 80 4394 4602
Plot No.35, 4th Phase, Malur KIADBSE DECISION MADE: 28-SEP-21
Malur, Kolar District IN 563130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Vitamin D total III
Roche Diagnostics 510(k) NO: K210901(Traditional)
ATTN: Jamie Ferguson PHONE NO : 317 2707402
9115 Hague Road PO Box 50416 SE DECISION MADE: 01-SEP-21
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Sichuan Prius Biotechnology Co., L510(k) NO: K210908(Traditional)
ATTN: Yan Liu PHONE NO : 86 831 3839889
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 26-SEP-21
Yibin CN 644104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LuxaPrint Ortho Plus
DMG Digital Enterprises SE 510(k) NO: K210940(Traditional)
ATTN: Stephan Schafer PHONE NO : 4940 84006
Elbgaustrasse 248 SE DECISION MADE: 03-SEP-21
Hamburg DE 22547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leonardo Mini Blue
CeramOptec GmbH 510(k) NO: K210951(Abbreviated)
ATTN: Roland Dreschau PHONE NO : 49 228 979670
Siemensstrabe 44 SE DECISION MADE: 01-SEP-21
Bonn DE D-53121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kubtec Mozart Supra (XPERT 84) Radiography System
KUB Technologies, Inc. 510(k) NO: K210955(Special)
ATTN: Chester Lowe PHONE NO : 203 3648544
111 Research Drive SE DECISION MADE: 20-SEP-21
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreferX Delivery System
MD3 LLC 510(k) NO: K210997(Traditional)
ATTN: Mary Ann Greenawalt PHONE NO : 503 3187722
3650 Coral Ridge Drive Suite 107 SE DECISION MADE: 07-SEP-21
Coral Springs FL 33065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Foshan Kangkang Biotechnology Co.,510(k) NO: K211073(Traditional)
ATTN: Yico Xie PHONE NO : 86 1370 2554142
2nd Floor, Building 4, Dongfang InSE DECISION MADE: 21-SEP-21
Foshan City CN 528225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Univers Revers Modular Glenoid System, Standard Augment Baseplates
Arthrex Inc. 510(k) NO: K211074(Traditional)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 02-SEP-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Banyan USA Surgical Mask Level 3
Banyan USA LLC 510(k) NO: K211097(Traditional)
ATTN: Ricardo Ryan PHONE NO : 631 4565447
390 Oser Avenue SE DECISION MADE: 22-SEP-21
Hauppauge NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
Health & Life Co., Ltd 510(k) NO: K211127(Traditional)
ATTN: Peggy Su PHONE NO :
9F, No. 186, Jian Yi Road, ZhongheSE DECISION MADE: 08-SEP-21
New Taipei City TW 23553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NTI ClenchGuard
Boyd Research, Inc. 510(k) NO: K211158(Traditional)
ATTN: James Boyd PHONE NO : 858 3429802
5820 Bali Way S SE DECISION MADE: 17-SEP-21
St. Pete Beach FL 33706 510(k) STATEMENT
DEVICE: IPL Hair Removal
Shenzhen Qiaochengli Technology Co510(k) NO: K211174(Traditional)
ATTN: LiPing Zhou PHONE NO : 86 0755 23072580
501-5, rujun building, 105 ZhongxiSE DECISION MADE: 01-SEP-21
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WoundExpress
Huntleigh Healthcare Ltd 510(k) NO: K211200(Traditional)
ATTN: Steve Monks PHONE NO : 44 2920 485885
35 Portmanmoor Road SE DECISION MADE: 03-SEP-21
Cardiff GB CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MagnetOs Easypack Putty
Kuros Biosciences B.V. 510(k) NO: K211201(Traditional)
ATTN: Marcel Borger PHONE NO : 31 30 2297280
Professor Bronkhorstlaan 10, buildSE DECISION MADE: 02-SEP-21
Bilthoven NL 3723MB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HTx Disposable Hysteroscope System
AcuVu Inc. 510(k) NO: K211227(Traditional)
ATTN: Sam Mostafavi PHONE NO : 650 6706972
4546 El Camino Real #211 SE DECISION MADE: 15-SEP-21
Los Altos CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RedEx
Advanced Surgical Concepts ltd 510(k) NO: K211234(Traditional)
ATTN: Edward Hyland PHONE NO : 353 1 2864777
Unit 4, Sunnybank Center, Upper DaSE DECISION MADE: 17-SEP-21
Bray IE A98 E339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRCUL8 Luxe DVT Prevention Device
Ortho8 Inc. 510(k) NO: K211235(Traditional)
ATTN: Taylor Nordeen PHONE NO : 1 916 2894002
2217 Plaza Drive SE DECISION MADE: 08-SEP-21
Rocklin CA 95765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Examination Gloves
Tangshan Hongyun Healthcare Produc510(k) NO: K211236(Traditional)
ATTN: Suying Le PHONE NO : 86 139 33365259
South Shenggezhuang Village, PachiSE DECISION MADE: 27-SEP-21
Tangshan CN 063500 510(k) STATEMENT
DEVICE: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
Promisemed Hangzhou Meditech Co., 510(k) NO: K211242(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 09-SEP-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFAI PACS Picture Archiving and Communication System
Ever Fortune.AI Co., Ltd. 510(k) NO: K211257(Traditional)
ATTN: Chen Ming-Fong PHONE NO : 886 4 23213838
Rm. D, 8F., NO. 573, Sec. 2, TaiwaSE DECISION MADE: 10-SEP-21
Taichung City TW 403020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIV-Clear cover
CIVCO Medical Instruments Co., Inc510(k) NO: K211270(Traditional)
ATTN: Jim Leong PHONE NO : 319 4002577
102 First Street South SE DECISION MADE: 13-SEP-21
Kalona IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
Innovative Health, LLC. 510(k) NO: K211276(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 15-SEP-21
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compressible Limb and Circulation Therapy System, Model POWER-Q2300
Wonjin Mulsan Co., Ltd. 510(k) NO: K211283(Traditional)
ATTN: Ha Yong Jung PHONE NO : 82 32 8160552
89, Geomdan-ro, Seo-gu SE DECISION MADE: 14-SEP-21
Incheon KR 22653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical face mask
Sunsmed Protective Products Ltd. 510(k) NO: K211296(Traditional)
ATTN: Joyce Lee PHONE NO : 86 152 71236397
No.18, Industrial park, Maozui TowSE DECISION MADE: 11-SEP-21
Xinatao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANNE One
Sibel Inc. 510(k) NO: K211305(Third Party - Traditional)
ATTN: Peter Xu PHONE NO : 224 2518859
6650 W Touhy Ave SE DECISION MADE: 14-SEP-21
Niles IL 60714 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Iovera System
Pacira Pharmaceuticals Inc. 510(k) NO: K211334(Special)
ATTN: Kent Jones PHONE NO : 510 9331513
46400 Fremont Blvd SE DECISION MADE: 10-SEP-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Thermometer (XHF2001, XHF2002)
Putian Hanjiang Huafeng Plastic Co510(k) NO: K211352(Traditional)
ATTN: Yiqian Deng PHONE NO : 86 15396 155566
40M road, Jiangkou Town, Hanjiang SE DECISION MADE: 09-SEP-21
Putian CN 351111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evo sEEG System
NeuroOne Medical Technologies Corp510(k) NO: K211367(Traditional)
ATTN: Joseph Ostendorf PHONE NO : 503 7846756
7599 Anagram Drive SE DECISION MADE: 01-SEP-21
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation 510(k) NO: K211375(Traditional)
ATTN: Donall Hosna PHONE NO : 651 5826323
4100 Hamline Ave North SE DECISION MADE: 10-SEP-21
St. Paul MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
Magstim Company Ltd. 510(k) NO: K211389(Traditional)
ATTN: Tom Campbell PHONE NO : 44 0 1994240798
Spring Gardens SE DECISION MADE: 14-SEP-21
Whitland GB SA34 0HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Small Bone Nailing System
Skeletal Dynamics, Inc. 510(k) NO: K211439(Traditional)
ATTN: Ana M Escagedo PHONE NO : 305 5967585
7300 N. Kendall Drive, Suite 400 SE DECISION MADE: 30-SEP-21
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Playboy 3 Contour Condom
Thai Nippon Rubber Industry Public510(k) NO: K211450(Traditional)
ATTN: Tossaporn Nilkhamhang PHONE NO : 66 38 317999
789/139 Pinthong Industrial EstateSE DECISION MADE: 30-SEP-21
Sriracha TH 20230 510(k) STATEMENT
DEVICE: Nitta M&T Safety Box
Nitta M&T (Thailand) Co., Ltd. 510(k) NO: K211464(Traditional)
ATTN: Takumi Moro PHONE NO : 66 2 5204803
19/52 Unit G5, Phaholyothin Rd., MSE DECISION MADE: 14-SEP-21
Khlong Luang TH 12120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kleiner KG2 System
Baat Medical Products BV 510(k) NO: K211474(Traditional)
ATTN: Kelsey van Abbema PHONE NO : 31 088 5656600
F. Hazemeijerstraat 800, Building SE DECISION MADE: 14-SEP-21
Hengelo NL 7555RJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Examination Powder Free Gloves
Aspen Glove Sdn. Bhd. 510(k) NO: K211477(Abbreviated)
ATTN: Iskandar Basha bin Abdul KadPHONE NO : 604 227 5000
Aspen House, 300, JLN Macalister SE DECISION MADE: 20-SEP-21
Georgetown MY 10450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Surgical Gloves Powder Free
Aspen Glove Sdn. Bhd. 510(k) NO: K211478(Abbreviated)
ATTN: Iskandar Basha bin Abdul KadPHONE NO : 604 2275000
Aspen House, 300, JLN Macalister SE DECISION MADE: 16-SEP-21
Georgetown MY 10450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Examination Glove Powder Free
Aspen Glove Sdn. Bhd. 510(k) NO: K211479(Abbreviated)
ATTN: Iskandar Basha bin Abdul KadPHONE NO : 604 2275000
Aspen House, 300, JLN Macalister, SE DECISION MADE: 16-SEP-21
Georgetown MY 10450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E10
GE Healthcare 510(k) NO: K211488(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 10-SEP-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris X Unidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation 510(k) NO: K211494(Traditional)
ATTN: Donall Hosna PHONE NO : 612 5826323
4100 Hamline Ave North SE DECISION MADE: 14-SEP-21
St. Paul MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encore Hip Stem
Signature Orthopaedics Pty Ltd. 510(k) NO: K211505(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 24-SEP-21
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIONAIRE UK Patient Matched Cutting Guides
Smith & Nephew, Inc. 510(k) NO: K211512(Traditional)
ATTN: Leah Hawkins PHONE NO : 901 4638447
7135 Goodlett Farms Parkway SE DECISION MADE: 16-SEP-21
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Welspun Health Surgical Mask
Welspun India Limited 510(k) NO: K211536(Traditional)
ATTN: Satyapriya Dash PHONE NO : 91 735 9072111
Survey No. 719, Village: VersamediSE DECISION MADE: 01-SEP-21
District:Kutch IN 370 110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
Bolder Surgical, LLC. 510(k) NO: K211579(Traditional)
ATTN: Nicholas Wong PHONE NO : 720 2877130
331 S. 104th Street, Suite 200 SE DECISION MADE: 07-SEP-21
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, Model: HW-1
Dongguan SIMZO Electronic Technolo510(k) NO: K211583(Traditional)
ATTN: Jinlong Wang PHONE NO : 86 769 22988335
No. 6 Zhangzhou Road, Daojiao TownSE DECISION MADE: 03-SEP-21
Dongguan CN 523187 510(k) STATEMENT
DEVICE: NAEOTOM Alpha, Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K211591(Traditional)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 30-SEP-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enteral Pump Syringe
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K211593(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 86205183
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 30-SEP-21
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Medical Systems 510(k) NO: K211597(Traditional)
ATTN: Brenna Loufek PHONE NO : 651 2471503
22100 Bothell Everett HWY SE DECISION MADE: 08-SEP-21
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
STERIS Corporation 510(k) NO: K211607(Traditional)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 07-SEP-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AROMA GRAND
Daeju Meditech Engineering Co., Lt510(k) NO: K211637(Traditional)
ATTN: Seongun Kim PHONE NO : 82 2 22080905
#501-504, HausD Sejong Tower, 26, SE DECISION MADE: 03-SEP-21
Seoul KR 04793 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
Changzhou Universal Medical Equipm510(k) NO: K211667(Traditional)
ATTN: Jerry Gao PHONE NO : 86 133 82802871
No. 6, Xinxi Road, Xinbei DistrictSE DECISION MADE: 23-SEP-21
Changzhou CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Gloves
Changzhou Yihua Sanitation Materia510(k) NO: K211673(Traditional)
ATTN: Ding Jie PHONE NO : 614 01589995
Sanhekou Village, Zhenglu Town, TiSE DECISION MADE: 01-SEP-21
Changzhou CN 213000 510(k) STATEMENT
DEVICE: KEYSTONE PEEK Cage System
Shanghai Sanyou Medical Co, LTD 510(k) NO: K211689(Traditional)
ATTN: David Fan PHONE NO : 86 21 58389980
385 Huirong Road SE DECISION MADE: 21-SEP-21
Jiading District CN 201815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzDent Web
Ewoosoft Co., Ltd 510(k) NO: K211700(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 28-SEP-21
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
Shenzhen OSTO Technology Company L510(k) NO: K211736(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 05-SEP-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rotarex Atherectomy System
C.R. Bard, Inc. 510(k) NO: K211738(Traditional)
ATTN: Aaron Conovaloff PHONE NO : 602 8305453
1625 West 3rd St SE DECISION MADE: 14-SEP-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DualX
Amplify Surgical, Inc. 510(k) NO: K211740(Special)
ATTN: Andy Choi PHONE NO : 949 6984854
9272 Jeronimo Rd Suite 107B SE DECISION MADE: 29-SEP-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable NIBP Cuff
Shenzhen Coreray Technology Co., L510(k) NO: K211747(Traditional)
ATTN: Simon Fan PHONE NO : 86 755 21010817
Floor 5, Building 10, HuangbeilingSE DECISION MADE: 23-SEP-21
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELLTRUST WT-III Mask with Flat Earloop
Lonestar Meadows LLC 510(k) NO: K211751(Traditional)
ATTN: Karthik Sundaram PHONE NO : 479 2955820
8585 Commerce Park Dr., Suite 500 SE DECISION MADE: 17-SEP-21
Houston TX 77036 510(k) STATEMENT
DEVICE: Panther OIS
Prowess Inc. 510(k) NO: K211760(Traditional)
ATTN: Rachel Scarano PHONE NO : 925 3560360
1844 Clayton Road SE DECISION MADE: 28-SEP-21
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altor Safety 4-Ply Surgical Mask (Model:62232)
Altor Safety LLC 510(k) NO: K211762(Traditional)
ATTN: Jared Scott PHONE NO : 1 845 4228320
711 Executive Boulevard Suite C SE DECISION MADE: 03-SEP-21
Valley Cottage NY 10989 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneLIF Intervertebral Body Replacement System
NovApproach Spine 510(k) NO: K211769(Traditional)
ATTN: Ronald P. Green PHONE NO : 352 3182584
13900 Tech City Circle, Suite 300 SE DECISION MADE: 07-SEP-21
Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves, Green/ Blue/ Black Color
Zhenjiang SuHui Latex Products Co.510(k) NO: K211778(Traditional)
ATTN: Zhengfu Sun PHONE NO : 86 138 05299882
Lianhe Village, Xinba Town SE DECISION MADE: 02-SEP-21
Yangzhong CN 212212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Gloves
Jiangsu Jinke Protective Equipment510(k) NO: K211781(Traditional)
ATTN: Mia Lai PHONE NO : 86 180 58186617
West Shuangyang Road(South Side), SE DECISION MADE: 29-SEP-21
Suqian CN 223900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable surgical mask
Shanghai No.9 Knitting Mill Co., L510(k) NO: K211794(Traditional)
ATTN: Wang Yipei PHONE NO : 021 58128888
No.555 Kangwu Road, Pudong New DisSE DECISION MADE: 28-SEP-21
Shanghai CN 201315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
Alphatec Spine, Inc. 510(k) NO: K211805(Traditional)
ATTN: Sandy Gill PHONE NO : 760 4946633
1950 Camino Vida Roble SE DECISION MADE: 22-SEP-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonine Acupressure Bands
WellSpring Pharmaceutical Corporat510(k) NO: K211823(Traditional)
ATTN: Renee Davis Grandchamp PHONE NO : 412 9445501
5911 North Honore Avenue, Suite 21SE DECISION MADE: 01-SEP-21
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K211824(Traditional)
ATTN: Scully Kim PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 09-SEP-21
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
Zhejiang Lanhine Medical Products 510(k) NO: K211827(Traditional)
ATTN: Jerry Gu PHONE NO : 86 0574 63970705
1989 Cidong Road, Cidongbinhai DisSE DECISION MADE: 23-SEP-21
Cixi CN 315300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Exceed LB
Canon Medical Systems Corporation 510(k) NO: K211828(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 10-SEP-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
Zhejiang Lanhine Medical Products 510(k) NO: K211832(Traditional)
ATTN: Jerry Gu PHONE NO : 86 0574 63970705
1989 Cidong Road, Cidongbinhai DisSE DECISION MADE: 08-SEP-21
Cixi CN 315300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gammaCore Sapphire
Electrocore, Inc. 510(k) NO: K211856(Traditional)
ATTN: Mike Romaniw PHONE NO : 973 3556702
200 Forge Way, Suite 205 SE DECISION MADE: 10-SEP-21
Rockaway NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation 11.0
RaySearch Laboratories AB (publ) 510(k) NO: K211867(Traditional)
ATTN: David Hedfors PHONE NO : 46 8 51053000
Sveavägen 44 SE DECISION MADE: 08-SEP-21
Stockholm SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI Segmentation
Varian Medical Systems, Inc. 510(k) NO: K211881(Traditional)
ATTN: Peter Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 02-SEP-21
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Glove
Jiangsu Dihong Industry and Trade 510(k) NO: K211904(Traditional)
ATTN: Sue Chen PHONE NO : 86 187 61104047
Dongxiaodian Industrial Park SE DECISION MADE: 17-SEP-21
Shuyang CN 223616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment intel510(k) NO: K211922(Traditional)
ATTN: Luo Huajun PHONE NO : 86 0755 33253598
Rm. 501, Bldg. 4, Haoer Jiashitai SE DECISION MADE: 20-SEP-21
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Digital Thermometer Non-Lubricated Probe Sheath
Medline Industries, Inc. 510(k) NO: K211931(Traditional)
ATTN: Kelsey Closen PHONE NO : 847 9482283
Three Lakes Drive SE DECISION MADE: 20-SEP-21
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIO-Ti Intervertebral Body Fusion Cage System
SpineCraft, LLC 510(k) NO: K211935(Traditional)
ATTN: Ami Akallal-Asaad PHONE NO : 630 9207300
777 Oakmont Lane, Suite 200 SE DECISION MADE: 30-SEP-21
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 Diagnostic Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K211945(Traditional)
ATTN: Scully KIM PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 08-SEP-21
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SubtlePET
Subtle Medical, Inc. 510(k) NO: K211964(Traditional)
ATTN: Ajit Shankaranarayanan PHONE NO : 650 3978709
883 Santa Cruz Ave, Suite 205 SE DECISION MADE: 28-SEP-21
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omeza Collagen Matrix
Omeza, LLC 510(k) NO: K211972(Traditional)
ATTN: Thomas Gardner PHONE NO : 941 7805274
25 South Osprey Avenue SE DECISION MADE: 01-SEP-21
Sarasota FL 34236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI Cocaine Metabolite Assay
Microgenics Corporation 510(k) NO: K211973(Traditional)
ATTN: Nikhita Tandon PHONE NO : 510 9795000
46500 Kato Road SE DECISION MADE: 24-SEP-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED PHOTIC System
Micromed S.p.A. 510(k) NO: K211974(Traditional)
ATTN: Nicola Rizzo PHONE NO : 39 041 5937000
Via Giotto 2 SE DECISION MADE: 23-SEP-21
Mogliano Veneto IT 31021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexta PEEK Hammertoe Correction System
Nextremity Solutions, Inc. 510(k) NO: K211996(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
1195 Polk Drive SE DECISION MADE: 23-SEP-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Vinyl Examination Gloves
Yunnan Huazhiyuan Medical Technolo510(k) NO: K212002(Traditional)
ATTN: Yun Gao PHONE NO : 86 182 52909158
Yangjie Industrial Park,Jianshui CSE DECISION MADE: 23-SEP-21
Honghe Hani and Yi Autonomous Pref510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Gloves
Jiangsu Shenglijie Safety Products510(k) NO: K212009(Traditional)
ATTN: Andy Jiang PHONE NO : 86 138 13628939
No.88 SI Road SE DECISION MADE: 15-SEP-21
Nantong CN 226401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6430 MyLabX75, 6430 MyLab XPro75
Esaote S.p.A. 510(k) NO: K212021(Traditional)
ATTN: Alberto Carcagni PHONE NO : 39 055 4229365
Via Enrico Melen 77 SE DECISION MADE: 16-SEP-21
Genoa IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amplatzer Steerable Delivery Sheath
Abbott Medical 510(k) NO: K212026(Traditional)
ATTN: Dan Gapp PHONE NO : 612 2898887
5050 Nathan Lane North SE DECISION MADE: 27-SEP-21
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dark Star Navigation Instrument System
Republic Spine, LLC 510(k) NO: K212028(Traditional)
ATTN: James Doulgeris PHONE NO : 561 3628094
2424 N Federal HW, Suite 257 SE DECISION MADE: 27-SEP-21
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoftSpot
PediaMetrix, Inc. 510(k) NO: K212045(Traditional)
ATTN: Joshua D Levin PHONE NO : 301 2192712
155 Gibbs Street, Suite 537 SE DECISION MADE: 28-SEP-21
Rockville MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longeviti ClearFit™ OTS Cranial Implants
Longeviti Neuro Solutions, LLC 510(k) NO: K212058(Traditional)
ATTN: Heather Hourihan PHONE NO : 410 5271803
303 International Circle Suite 190SE DECISION MADE: 08-SEP-21
Hunt Valley MD 21030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation 510(k) NO: K212067(Traditional)
ATTN: Katelyn Rowley PHONE NO : 2 623 095888
7-127, 4-Chome, Asahigaoka, SE DECISION MADE: 17-SEP-21
Hino JP 191-8503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Imaging Plate Scanner, i-Scan
Guilin Woodpecker Medical Instrume510(k) NO: K212080(Traditional)
ATTN: Xunxian Wu PHONE NO : 86 773 2350532
Information Industrial Park, GuiliSE DECISION MADE: 27-SEP-21
Guilin City CN 541004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
3M Company 510(k) NO: K212081(Special)
ATTN: Mary Fretland PHONE NO : 651 4612734
3M Center, Building 275-5W-06 SE DECISION MADE: 05-SEP-21
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Red Wave Hair Removal
Shenzhen Accompany Technology Co.,510(k) NO: K212099(Traditional)
ATTN: Yourong Lai PHONE NO : 0086 0755 22674547
Unit. 375, Xiangnan Ruifeng GradanSE DECISION MADE: 24-SEP-21
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynamic TiBase
Talladium España, SL 510(k) NO: K212108(Traditional)
ATTN: Xavier Soca Filella PHONE NO : 34 973 289580
C/ Virginia Woolf, 17 SE DECISION MADE: 24-SEP-21
Lleida ES 25005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
Nobel Biocare AG 510(k) NO: K212125(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
P.O. Box, 8058 Zurich - Airport SE DECISION MADE: 24-SEP-21
Balsberg, Balz Zimmermann-Str. 7 510(k) STATEMENT
DEVICE: Persona® Personalized Knee System
Zimmer Switzerland Manufacturing G510(k) NO: K212129(Traditional)
ATTN: Thomas Lincoln PHONE NO : 0041 58 8548257
Sulzerallee 8 SE DECISION MADE: 28-SEP-21
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
Cochlear Americas 510(k) NO: K212136(Traditional)
ATTN: Whitney Alexander PHONE NO : 303 2642123
10350 Park Meadows Dr SE DECISION MADE: 29-SEP-21
Lone Tree CO 80124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Admiral ACP System
SeaSpine Orthopedics Corporation 510(k) NO: K212139(Traditional)
ATTN: Cindy Fong PHONE NO : 949 8557175
5770 Armada Drive SE DECISION MADE: 01-SEP-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimpleSENSE Platform
Nanowear Inc. 510(k) NO: K212160(Special)
ATTN: Venkatesh Varadan PHONE NO : 718 6374815
53 Boerum Place, Suite 3F SE DECISION MADE: 22-SEP-21
Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips IntelliVue GuardianSoftware (Rev. E.0X)
Philips Medizin Systeme Boeblingen510(k) NO: K212208(Third Party - Traditional)
ATTN: Johannes Schmid PHONE NO : 0049 175 5177024
Hewlett-Packard Str. 2 SE DECISION MADE: 30-SEP-21
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HandX
Human Xtensions Ltd. 510(k) NO: K212214(Traditional)
ATTN: Maija Wallenstein PHONE NO : 972 77 3630316
4 Meir Ariel St. SE DECISION MADE: 13-SEP-21
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Imperative Care Inc. 510(k) NO: K212224(Special)
ATTN: Kristin Ellis PHONE NO : 408 8570934
1359 Dell Avenue SE DECISION MADE: 20-SEP-21
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR Safety Syringe, Sterile Hypodermic needle for Single use
Zhuhai DR Medical Instruments Co.,510(k) NO: K212226(Third Party - Traditional)
ATTN: Xu Jianhai PHONE NO : 086 0756 7770668
Floor 4, Factory Building A, No.28SE DECISION MADE: 29-SEP-21
Zhuhai CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Philips MR Patient Care Portal
Invivo Corporation 510(k) NO: K212227(Traditional)
ATTN: Maria Keelan PHONE NO : 407 4735510
12151 Research Parkway SE DECISION MADE: 30-SEP-21
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TheraFace Microcurrent
Theragun, Inc. 510(k) NO: K212238(Traditional)
ATTN: Jaime Sanchez PHONE NO : 310 5708341
6100 Wilshire Blvd, Suite 200 SE DECISION MADE: 29-SEP-21
Los Angeles CA 90048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exofin Precision Pen
Chemence Medical, Inc. 510(k) NO: K212246(Special)
ATTN: Charnelle Thomas PHONE NO : 678 7890760
200 Technology Drive SE DECISION MADE: 09-SEP-21
Alpharetta GA 30115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intelligent NR
Canon Inc. 510(k) NO: K212269(Traditional)
ATTN: Akira Hirai PHONE NO : 81 33 7582111
9-1 Imaikami-cho, Nakahara-ku SE DECISION MADE: 17-SEP-21
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tempo Natural Tampon
Dong-A Pharmaceutical Co., Ltd. 510(k) NO: K212272(Traditional)
ATTN: Hyunjeong Jang PHONE NO : 82 2 9208289___
64 Cheonho-daero, Dongdaemun-gu SE DECISION MADE: 17-SEP-21
Seoul KR 02587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioRoot Flow 0.5g, BioRoot Flow 2g
Septodont 510(k) NO: K212283(Traditional)
ATTN: Kimty Bui Van PHONE NO : 33 149 767116
58, rue du Pont De Creteil SE DECISION MADE: 16-SEP-21
Saint-Maur des Fosses Cedex FR 94510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dayspring Lite
Koya Medical, Inc. 510(k) NO: K212287(Special)
ATTN: Jarren Baldwin PHONE NO : 1 773 9541371
2461 Peralta St. SE DECISION MADE: 21-SEP-21
Oakland CA 94607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX
Sedecal SA 510(k) NO: K212291(Traditional)
ATTN: Mª Luisa Gómez de Agüero PHONE NO : 34 91 6280544
C/ Pelaya, 9 - 13 Pol. Ind. Río DeSE DECISION MADE: 14-SEP-21
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2
Osstem Implant Co., Ltd. 510(k) NO: K212303(Traditional)
ATTN: Jinwoo Bae PHONE NO : 82 70 46260701
2 Floor, B-dong, 51, Mayu-ro 238beSE DECISION MADE: 21-SEP-21
Siheung-si KR 15079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (10 pack)
3M Health Care Business Group 510(k) NO: K212320(Traditional)
ATTN: Teri Feeley PHONE NO : 210 4591952
6203 Farinon Dr. SE DECISION MADE: 28-SEP-21
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JiveX (Model Number / Release: 5.3)
Visus Health IT GmbH 510(k) NO: K212321(Traditional)
ATTN: Axel Schreiber PHONE NO : 49 234 93693337
Gesundheitscampus-Sued 15-17 SE DECISION MADE: 23-SEP-21
Bochum DE 44801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiscCath Needle Set
DiscCath LLC 510(k) NO: K212328(Traditional)
ATTN: Gregory E. Lutz PHONE NO : 609 3562449
62 E 88th Street SE DECISION MADE: 26-SEP-21
New York NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEO Extremity and Ankle Plating System
Gramercy Extremity Orthopedics, LL510(k) NO: K212334(Traditional)
ATTN: Michael P. Simpson PHONE NO : 855 4392278
1239 N. Glenville Dr. SE DECISION MADE: 21-SEP-21
Richardson TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIIP+ Device
ZIIP, Inc 510(k) NO: K212342(Traditional)
ATTN: David Mason PHONE NO : 415 3193639
1425 Leimert Blvd, Suite 202 SE DECISION MADE: 23-SEP-21
Oakland CA 94062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DB-EZ Bone Void Filler
Dimensional Bioceramics, LLC. 510(k) NO: K212353(Traditional)
ATTN: Duran N. Yetkinliner PHONE NO : 408 7576603
2161 Delaware Avenue, Suite A SE DECISION MADE: 22-SEP-21
Santa Cruz CA 95060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AngioVac F18 85
AngioDynamics, Inc. 510(k) NO: K212386(Traditional)
ATTN: Kasey E. Newcomb PHONE NO : 508 6587813
603 Queensbury Ave SE DECISION MADE: 30-SEP-21
Queensbury NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE™ Anterior Cervical Plate System
Evolution Spine 510(k) NO: K212405(Abbreviated)
ATTN: Todd Wallenstein PHONE NO : 571 5947409
2300 N. Haskell Ave SE DECISION MADE: 30-SEP-21
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc. 510(k) NO: K212411(Traditional)
ATTN: Kara Johnson PHONE NO : 781 3459122
600 Technology Park Drive, 4th FloSE DECISION MADE: 23-SEP-21
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIS-XP
Medicore Co., Ltd. 510(k) NO: K212412(Traditional)
ATTN: Kyo-bum Kim PHONE NO : 82 2 20562600
SE DECISION MADE: 13-SEP-21
Seongnam-si KR 13207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAS 3D
Adas3D Medical S.L 510(k) NO: K212421(Special)
ATTN: Antonio Riu PHONE NO : 0034 93 3283964
Paris 179, 2-2 SE DECISION MADE: 03-SEP-21
Barcelona ES 08036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
ReMade USA LLC 510(k) NO: K212451(Third Party - Traditional)
ATTN: David Durst PHONE NO : 323 5785448
2915 E Washington Blvd SE DECISION MADE: 10-SEP-21
Los Angeles CA 90023 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KARL STORZ Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy America, Inc.510(k) NO: K212476(Special)
ATTN: Winkie Wong PHONE NO : 310 6583427
2151 E. Grand Ave SE DECISION MADE: 03-SEP-21
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Relax Pro Model AR-4.0
Diode Art Engineering doing busine510(k) NO: K212491(Third Party - Traditional)
ATTN: Beomjoon Lee PHONE NO : 1 323 2854231
9535 Brasher St SE DECISION MADE: 02-SEP-21
Pico Rivera CA 90660 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Lung Image Analysis
Pulmonx Corporation 510(k) NO: K212494(Third Party - Traditional)
ATTN: Terry Solomon PHONE NO : 650 2160195
700 Chesapeake Drive SE DECISION MADE: 02-SEP-21
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Leva Pelvic Health System
Renovia Inc. 510(k) NO: K212495(Special)
ATTN: Jim O'Connor PHONE NO : 860 5103026
263 Summer St. 5th Floor SE DECISION MADE: 08-SEP-21
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Explorer TO System
SeaSpine Orthopedics Corporation 510(k) NO: K212540(Special)
ATTN: Aly Alvarez PHONE NO : 619 8844342
5770 Armada Drive SE DECISION MADE: 10-SEP-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-Pro, D1
Canon Inc. 510(k) NO: K212553(Special)
ATTN: Akira Hirai PHONE NO : 81 33 7582111
9-1 Imaikami-cho, Nakahara-ku SE DECISION MADE: 09-SEP-21
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: mi-eye 3 needlescope with cannula, mi-tablet 3
Trice Medical, Inc. 510(k) NO: K212556(Special)
ATTN: David Vancelette PHONE NO : 949 2388220
40 General Warren Blvd, Suite 100 SE DECISION MADE: 15-SEP-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Virtual C DRF-NEO Digital Imaging System
Portavision Medical LLC 510(k) NO: K212557(Traditional)
ATTN: Terry Ancar PHONE NO : 866 7834133
800 Central Avenue SE DECISION MADE: 24-SEP-21
Jefferson LA 70121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symbia VA10A Family
Siemens Medical Solutions USA, Inc510(k) NO: K212604(Special)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 16-SEP-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeamSite
DoseOptics LLC 510(k) NO: K212606(Special)
ATTN: Venkat Krishnaswamy PHONE NO : 802 7270123
16 Cavendish Ct SE DECISION MADE: 15-SEP-21
Lebanon NH 03766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StrataMR II Valves and Shunts
Medtronic Neurosurgery 510(k) NO: K212641(Special)
ATTN: Swara Vashi PHONE NO : 267 6388778
5290 California Avenue SE DECISION MADE: 16-SEP-21
Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERSEAL Curved Jaw Sealer and Divider, Double Action
Olympus Surgical Technologies Amer510(k) NO: K212643(Special)
ATTN: Christina Flores PHONE NO : 508 8083341
9600 Louisiana Blvd North SE DECISION MADE: 27-SEP-21
Brooklyn Park MN 55455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flyte
Pelvital USA, Inc. 510(k) NO: K212655(Special)
ATTN: Dale Wahlstrom PHONE NO : 612 8041319
1000 LaSalle Avenue, SCH 435 SE DECISION MADE: 21-SEP-21
Minneapolis MN 55403 510(k) STATEMENT
DEVICE: Smylio Invisible Clear Aligners
Smylio, Inc 510(k) NO: K212660(Special)
ATTN: Ren Menon PHONE NO : 510 8682184
48890 Milmont Dr. SE DECISION MADE: 22-SEP-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Guide Sheath Kit-401, K-402
Olympus Medical Systems Corp. 510(k) NO: K212667(Special)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 22-SEP-21
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viveve System, Viveve 2.0 System
Viveve Medical, Inc. 510(k) NO: K212678(Special)
ATTN: Kevin Robison PHONE NO : 317 4358898
345 Inverness Drive South, BuildinSE DECISION MADE: 14-SEP-21
Englewood CO 80109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONICAMINOLTA DI-X1
Konica Minolta, Inc. 510(k) NO: K212685(Special)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 13-SEP-21
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mariner Pedicle Screw System
SeaSpine Orthopedics Corporation 510(k) NO: K212692(Special)
ATTN: Jesse Albright PHONE NO : 760 2165176
5770 Armada Drive SE DECISION MADE: 21-SEP-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Philips Medical Systems 510(k) NO: K212704(Third Party - Traditional)
ATTN: Brenna Loufek PHONE NO : 651 2471503
22100 Bothell Everett HWY SE DECISION MADE: 24-SEP-21
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Halo One Thin-Walled Guiding Sheath
C.R.Bard, Inc 510(k) NO: K212708(Special)
ATTN: Annmarie Fitzgerald PHONE NO : 353 53 9237111
Moyne Upper SE DECISION MADE: 23-SEP-21
Enniscorthy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL UNITE™ Platform Shoulder System
DePuy Ireland UC 510(k) NO: K212710(Special)
ATTN: Yayoi Fujimaki PHONE NO : 508 8283541
Loughbeg Ringaskiddy SE DECISION MADE: 15-SEP-21
Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViperCross Support Catheters
Cardiovascular Systems, Inc. 510(k) NO: K212725(Special)
ATTN: Erika Huffman PHONE NO : 651 2591608
1225 Old Highway 8 NW SE DECISION MADE: 24-SEP-21
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Pneumonia Panel
BioFire Diagnostics, LLC 510(k) NO: K212727(Special)
ATTN: Kevin Bourzac PHONE NO : 801 7366354 1358
515 Colorow Drive SE DECISION MADE: 22-SEP-21
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Bougie, 38 Fr. and Hand Pump
Standard Bariatrics 510(k) NO: K212728(Special)
ATTN: Michelle Schnell PHONE NO : 1 513 7026083
4362 Glendale Milford Rd. SE DECISION MADE: 23-SEP-21
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amplatzer Talisman Delivery Sheath
Abbott Medical 510(k) NO: K212738(Special)
ATTN: Daniel Gapp PHONE NO : 651 7563329
177 East County Road B SE DECISION MADE: 27-SEP-21
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
Waldemar Link GmbH & Co. KG 510(k) NO: K212742(Special)
ATTN: Lydia Ditter PHONE NO : 49 40 53575 530
Oststraße 4-10 SE DECISION MADE: 16-SEP-21
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Da Vinci SP Surgical System
Intuitive Surgical, Inc. 510(k) NO: K212747(Special)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 29-SEP-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Surgical Aspirator System, Model: XD880B
SMTP Technology Co., Ltd. 510(k) NO: K212750(Special)
ATTN: Songtao Zhan PHONE NO : 86 010 88572898
1F&4F, Building A, Emerging IndustSE DECISION MADE: 27-SEP-21
Zhangjiagang CN 215634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jada System
Alydia Health 510(k) NO: K212757(Special)
ATTN: Colby Holtshouse PHONE NO : 650 2753772
3495 Edison Way SE DECISION MADE: 30-SEP-21
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collaboration Live
Philips Ultrasound, Inc. 510(k) NO: K212777(Special)
ATTN: Courtney Nix PHONE NO : 203 2136862
22100 Bothell Everett Highway SE DECISION MADE: 24-SEP-21
Bothell WA 98201-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
Medynus Inc. 510(k) NO: K212792(Traditional)
ATTN: David Shin PHONE NO : 949 9320847
18 Technology Dr. Ste 109 SE DECISION MADE: 23-SEP-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accuray Precision Treatment Planning System
Accuray Incorporated 510(k) NO: K212794(Special)
ATTN: Lizhi Yu PHONE NO : 608 8242885
1209 Deming Way SE DECISION MADE: 30-SEP-21
Madison WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriCap Mini Needle and Standard Needles
OcuJect, LLC 510(k) NO: K212805(Special)
ATTN: Rebecca K. Pine PHONE NO : 760 8095178
1441 Avocado Ave, Suite 204 SE DECISION MADE: 30-SEP-21
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProxiDiagnost N90
Philips Medical Systems DMC GmbH 510(k) NO: K212837(Special)
ATTN: Supriya Dalvi PHONE NO : 49 405 0782425
Roentgenstrasse 24-26 SE DECISION MADE: 21-SEP-21
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMILERS
Biotech Dental Smilers, SAS 510(k) NO: K212961(Third Party - Traditional)
ATTN: Delphine Mercier PHONE NO : 33 04 90446060
305, Allée de craponne SE DECISION MADE: 20-SEP-21
Salon de Provence FR 13300 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 261
TOTAL WITH SUMMARIES 247
TOTAL WITH STATEMENTS 14
