510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2021
DEVICE: MEGA-TMS
Soterix Medical, Inc. 510(k) NO: K192823(Traditional)
ATTN: Abhishek Datta PHONE NO : 888 9908327
237 W 35 ST, 1401 SE DECISION MADE: 13-AUG-21
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kisses Plus Implant System
ACHIMHAI Medical Corporation 510(k) NO: K200193(Traditional)
ATTN: Ji Ho Jung PHONE NO : 82 70 42964318
28, Namyang-ro, 930beon-gil, NamyaSE DECISION MADE: 06-AUG-21
Hwaseong-si KR 18255 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptiva Celiac Disease IgG Reagent
Inova Diagnostics, Inc. 510(k) NO: K200230(Traditional)
ATTN: Andrea Seaman PHONE NO : 858 5869900 1395
9900 Old Grove Rd. SE DECISION MADE: 26-AUG-21
San Diego CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartGuard Anti-Snoring Device
SmartGuard Rx Inc. 510(k) NO: K200657(Traditional)
ATTN: Brian Larsen PHONE NO : 623 3493984
2112 North Hill Field Rd. Suite 2ASE DECISION MADE: 23-AUG-21
Layton UT 84041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visby Medical Sexual Health
Visby Medical 510(k) NO: K200748(Dual Track)
ATTN: Carolyn Glickman PHONE NO : 408 6508878
3010 N. First Street SE DECISION MADE: 26-AUG-21
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Tosoh Bioscience, Inc. 510(k) NO: K200904(Traditional)
ATTN: Louise Musante PHONE NO : 510 4599670
6000 Shoreline Court, Suite 101 SE DECISION MADE: 05-AUG-21
South San Francisco CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clearblue® Early Digital Pregnancy Test
SPD Swiss Precision Diagnostics Gm510(k) NO: K200913(Traditional)
ATTN: Joanne Scaife PHONE NO : 41 580047345
47 Route de St Georges, Petit-LancSE DECISION MADE: 13-AUG-21
Geneva CH ch-1213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI® B-Lac Cassette
OPTI Medical Systems, Inc. 510(k) NO: K200986(Traditional)
ATTN: Theron Gober PHONE NO : 770 6554919
235 Hembree Park Drive SE DECISION MADE: 02-AUG-21
Roswell GA 30114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: sOLVe Tube
HyTek Medical, Inc. 510(k) NO: K201026(Traditional)
ATTN: Nir Hoftman PHONE NO : 818 7017180
8741 Shirley Ave SE DECISION MADE: 10-AUG-21
Northridge CA 91324 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARK Lacosamide Assay
ARK Diagnostics, Inc. 510(k) NO: K201089(Traditional)
ATTN: Thomas Houts PHONE NO : 510 2706296
48089 Fremont Boulevard SE DECISION MADE: 05-AUG-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iMap 3D Mapping & Navigation System (iMap System)
CardioNXT, Inc. 510(k) NO: K201094(Traditional)
ATTN: Kirk Mackin PHONE NO : 720 4791025
12011 Tejon Street, Suite 700 SE DECISION MADE: 16-AUG-21
Westminster CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prime BIOFOAM® Multi-Hole Shells
MicroPort Orthopedics Inc. 510(k) NO: K201157(Traditional)
ATTN: Vaidehi Mehta PHONE NO : 901 8674402
5677 Airline Road SE DECISION MADE: 24-AUG-21
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
QualiMed USA, LLC. 510(k) NO: K201246(Traditional)
ATTN: Manfred Gulcher PHONE NO : 49 172 2368990
1800 Camden Rd, Suite 107 (P.O BoxSE DECISION MADE: 03-AUG-21
Charlotte NC 28203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
Aatru Medical LLC 510(k) NO: K201400(Traditional)
ATTN: James J. Rogers PHONE NO :
1301 East 9th Street, Suite 2700 SE DECISION MADE: 23-AUG-21
Cleveland OH 44114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto Lung Nodule Detection
Samsung Electronics Co.,Ltd. 510(k) NO: K201560(Traditional)
ATTN: Jaesang Noh PHONE NO : 82 2 21932444
129, Samsung-Ro, Yeongtong-Gu SE DECISION MADE: 31-AUG-21
Suwon-Si KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brain Perfusion (BP) application
Philips Medical Systems Nederland 510(k) NO: K201573(Traditional)
ATTN: Yoram Levy PHONE NO : 1 800 729377
Veenpluis 4-6 SE DECISION MADE: 17-AUG-21
Best Noord-Brabant NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Assure Tech (Hangzhou) Co., Ltd. 510(k) NO: K201630(Traditional)
ATTN: Shisheng Ling PHONE NO : 86 571 88868960
2nd-5th Floor, Building 4, No. 141SE DECISION MADE: 12-AUG-21
Hangzhou CN 310011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
Careplus (M) SDN BHD 510(k) NO: K201857(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 6 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 20-AUG-21
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
Fit-Pro Ltd. 510(k) NO: K202148(Traditional)
ATTN: Janos Papp PHONE NO : 36 304 772460
7 Szabadsag Ter SE DECISION MADE: 25-AUG-21
Budapest HU 1054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insignis Subcutaneous Needle Sets
Innovative Health Sciences, LLC 510(k) NO: K202279(Traditional)
ATTN: Andy Sealfon PHONE NO : 845 6105665
1108 Kings Highway, Suite 4 SE DECISION MADE: 13-AUG-21
Chester NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiLattice scaffold
Tepha, Inc. 510(k) NO: K202425(Traditional)
ATTN: Kavetha Ram PHONE NO : 781 3571700
99 Hayden Avenue, Suite 360 SE DECISION MADE: 19-AUG-21
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gowns
Anhui Medpurest Medical Technology510(k) NO: K202532(Traditional)
ATTN: Long Shushan PHONE NO : 86 556 5999022
No.188,Wenyuan Road, Zhumeng New ZSE DECISION MADE: 21-AUG-21
Anqing CN 246003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
YTY Industry (Manjung) SDN BHD 510(k) NO: K202536(Traditional)
ATTN: Punitha Samy PHONE NO : 605 690 8533
Lot 1422-1424, Batu 10 Lekir SE DECISION MADE: 11-AUG-21
Sitiawan MY 32020 510(k) STATEMENT
DEVICE: NeuroSENSE Monitoring System, Model NS-901
NeuroWave Systems Inc. 510(k) NO: K202621(Traditional)
ATTN: Tatjana Zikov PHONE NO : 216 3611591
2490 Lee Blvd, Ste 300 SE DECISION MADE: 05-AUG-21
Cleveland Heights OH 44118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metallic Fabric Electrodes
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K202636(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 66393598
No.23 Building, The Second Phase, SE DECISION MADE: 16-AUG-21
Guangzhou CN 511450 510(k) STATEMENT
DEVICE: Servator P SALF Solution with THAM
S.A.L.F. spa 510(k) NO: K202652(Traditional)
ATTN: Carmelo Gagliano PHONE NO : 39 035 940097
Via Marconi 2 SE DECISION MADE: 19-AUG-21
Cenate Sotto IT 24069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nam illumination probe with chopper
Oculight Ltd. 510(k) NO: K202670(Traditional)
ATTN: Jinman Kim PHONE NO : 82 031 80396177
Seongnamdaelo 1342, B111 SE DECISION MADE: 20-AUG-21
Seongnam-si KR 13120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prime and DYNASTY® Additive Manufacturing Shells
MicroPort Orthopedics Inc. 510(k) NO: K202705(Traditional)
ATTN: Gillen Gonzales PHONE NO : 901 8674400
5677 Airline Road SE DECISION MADE: 20-AUG-21
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable medical face mask
Ningbo Jingeao Electronics Inc. 510(k) NO: K202745(Traditional)
ATTN: Yiyun Yu PHONE NO : 86 188 00333393
No.2 Jinyuan Road, Longshan IndustSE DECISION MADE: 23-AUG-21
Cixi CN 315311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical mask
Ningbo Jingeao Electronics Inc. 510(k) NO: K202746(Traditional)
ATTN: Yiyun Yu PHONE NO : 86 188 00333393
No.2 Jinyuan Road, Longshan IndustSE DECISION MADE: 27-AUG-21
Cixi CN 315311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXS Vecta 46 Intermediate Catheter
Stryker Neurovascular 510(k) NO: K202752(Traditional)
ATTN: Shivani H. Patel PHONE NO : 510 4132772
47900 Bayside Parkway SE DECISION MADE: 27-AUG-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuspera Neurostimulation System (NNS)
Neuspera Medical Inc. 510(k) NO: K202781(Traditional)
ATTN: Alexander Yeh PHONE NO : 888 8468332 703
51 Daggett Dr. SE DECISION MADE: 27-AUG-21
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TT Electric Breast Pump, TT Double Electric Breast Pump
Wuxi Xinzhongrui Baby Supplies Co.510(k) NO: K202802(Traditional)
ATTN: Zhang Chunyan PHONE NO : 86 510 88150268
No. 117 Xinhua Road, Meicun, New WSE DECISION MADE: 26-AUG-21
Wuxi CN 214000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The iMask Child's Face Mask
Pac-Dent, Inc. 510(k) NO: K202831(Traditional)
ATTN: Jiahe Li PHONE NO : 909 8390888
670 Endeavor Circle SE DECISION MADE: 26-AUG-21
Brea CA 92821 510(k) STATEMENT
DEVICE: GX Navigation Instrument System
Life Spine Inc. 510(k) NO: K202836(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 19-AUG-21
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Needle Stimulator
Wuxi Jiajian Medical Instrument Co510(k) NO: K202861(Traditional)
ATTN: Caihong Sun PHONE NO : 86 510 88745788
No. 35 Baiqiao Rd., Ehu Town, XishSE DECISION MADE: 27-AUG-21
Wuxi CN 214116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balloon Guiding Catheter
Shanghai Heartcare Medical Technol510(k) NO: K202916(Traditional)
ATTN: Zongyu Xue PHONE NO : 86 18 621683501
590 Ruiqing Rd, Building 4, Suite SE DECISION MADE: 25-AUG-21
Shanghai CN 201201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amber Mill Q Series & Amber Mill Direct Series
HASS Corp. 510(k) NO: K202952(Traditional)
ATTN: Yongsu Kim PHONE NO : 82 70 77121300
77-14, Gwahakdanji-ro SE DECISION MADE: 26-AUG-21
Gangneung-si KR 25452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomet Microfixation OmniMax MMF System
Biomet Microfixation 510(k) NO: K202969(Traditional)
ATTN: Lauren Jasper PHONE NO : 904 7419259
1520 Tradeport Drive SE DECISION MADE: 05-AUG-21
Jacksonville FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2 Dermabrasion Tip (for Dermal Cooling System)
R2 Technologies, Inc. 510(k) NO: K203006(Traditional)
ATTN: Ragan Reppond PHONE NO : 510 8280007
2603 Camino Ramon, Suite 200 SE DECISION MADE: 05-AUG-21
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auxilock Titanium Interference Screw
Auxein Medical Private Limited 510(k) NO: K203029(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No. 168, 169, 170 Phase-IV, SSE DECISION MADE: 20-AUG-21
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ablamap Software
Ablacon, Inc. 510(k) NO: K203084(Traditional)
ATTN: Frank Rodrigues PHONE NO : 303 955763
4800 Wadsworth Blvd. Suite 310 SE DECISION MADE: 31-AUG-21
Wheat Ridge CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Dexcom, Inc. 510(k) NO: K203089(Traditional)
ATTN: Bryan Osborne PHONE NO : 760 6505590
6310 Sequence Dr. SE DECISION MADE: 17-AUG-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme PLAC® Test for Lp-PLA2 Activity
Diazyme Laboratories Inc. 510(k) NO: K203136(Special)
ATTN: Chao Dou PHONE NO : 858 4554763
12889 Gregg Court SE DECISION MADE: 06-AUG-21
Poway CA 92064 510(k) STATEMENT
DEVICE: Disposable Face Mask
Chaozhou Cecilia Technology Co., L510(k) NO: K203152(Traditional)
ATTN: Weng Yu PHONE NO : 86 663 2900999
Nanyuan Building A, Xiakeng, YintaSE DECISION MADE: 11-AUG-21
Chaozhou CN 515658 510(k) STATEMENT
DEVICE: Disposable Medical Mask
Dong Guan Kinyet Metal Products Co510(k) NO: K203174(Traditional)
ATTN: Emily Zhang PHONE NO : 86 769 86487999
NO.38, Weijian Road, Chashan Town,SE DECISION MADE: 02-AUG-21
DongGuan city CN 523380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys HCG STAT
ROCHE DIAGNOSTICS 510(k) NO: K203227(Traditional)
ATTN: Adennis N. Cora PHONE NO : 317 3134093
9115 Hague Road PO Box 50416 SE DECISION MADE: 18-AUG-21
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
Rhino Health Inc 510(k) NO: K203236(Traditional)
ATTN: Mark Lee PHONE NO : 1 833 8988989
309A East, Route 66 SE DECISION MADE: 16-AUG-21
Church Rock NM 87311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
Atlas Link Technology Co., Ltd. 510(k) NO: K203246(Traditional)
ATTN: Xiaoping Hao PHONE NO : 0086 10 8890912
Gu'an South Industry Zone SE DECISION MADE: 04-AUG-21
Langfang CN 065500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLOPASS System
inTRAvent Medical Partners, LP 510(k) NO: K203251(Traditional)
ATTN: Adam Barner PHONE NO : 1 717 5334000
421 W. Chocolate Ave. SE DECISION MADE: 27-AUG-21
Hershey PA 17036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tiger Reusable Sharps Container
International Marketing Specialist510(k) NO: K203305(Traditional)
ATTN: Rod Calderon PHONE NO : 606 6771450
1278 HWY 461 SE DECISION MADE: 06-AUG-21
Somerset KY 42503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premilled Titanium Block System
InnoBioSurg Co., Ltd. 510(k) NO: K203344(Traditional)
ATTN: Sun-Mi Park PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 25-AUG-21
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HVT 2.0
Vapotherm Inc. 510(k) NO: K203357(Traditional)
ATTN: Dennis Francoeur PHONE NO : 603 6580491
100 Domain Drive SE DECISION MADE: 25-AUG-21
Exeter NH 03833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACOE vario
TRACOE medical GmbH 510(k) NO: K203362(Traditional)
ATTN: Katharina Schrick PHONE NO : 49 613 69169323
Reichelsheimer Str. 1/3 SE DECISION MADE: 05-AUG-21
Nieder-Olm DE 55268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crosser iQ CTO Recanalization System
C.R. Bard, Inc. 510(k) NO: K203363(Traditional)
ATTN: Aaron Conovaloff PHONE NO : 480 5978220
1625 West 3rd St SE DECISION MADE: 12-AUG-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA SMARTPERIO
El.En. Electronic Engineering Spa 510(k) NO: K203396(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 23-AUG-21
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare510(k) NO: K203448(Traditional)
ATTN: Xin Gao PHONE NO : 86 21 67076888 5386
No. 2258 Chengei Rd., Jiading InduSE DECISION MADE: 11-AUG-21
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESS Dental Smart Solutions
Terrats Medical SL 510(k) NO: K203464(Traditional)
ATTN: Roger Terrats PHONE NO : 34 935 646006
Carrer Mogoda 75-99 SE DECISION MADE: 04-AUG-21
Barbera del Valles ES 08210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Otoplan
CAScination AG 510(k) NO: K203486(Traditional)
ATTN: Jean-Francois Clemence PHONE NO : 41 31 5520440
Steigerhubelstrasse 3 SE DECISION MADE: 20-AUG-21
Bern CH CH-3008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K203538(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 02-AUG-21
Northfield IL 60030 510(k) STATEMENT
DEVICE: Neodent Implant System - Mini Abutment 60°
JJGC Industria e Comercio de Mater510(k) NO: K203542(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 02-AUG-21
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnyOne External Implant System
MegaGen Implant Co., Ltd. 510(k) NO: K203554(Traditional)
ATTN: You Jung Kim PHONE NO : 82 53 2222828
45, Secheon-ro, 7-gil SE DECISION MADE: 28-AUG-21
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSS VRS Spinal System
Biedermann Motech GmbH & Co. KG 510(k) NO: K203607(Traditional)
ATTN: Gerd Federle PHONE NO : 49 7720 8510545
Bertha-von Suttner-Strasse 23 SE DECISION MADE: 20-AUG-21
Villingen-Schwenningen DE 78054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFit Reusable Enteral Syringe
Shantou Wealy Medical Instrument C510(k) NO: K203613(Traditional)
ATTN: Yang Songling PHONE NO : 0086 15 816758600
North Jinhuan Road (near Qishan miSE DECISION MADE: 27-AUG-21
Shantou CN 515064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Gloves
Beijing Biosis Healing Biological 510(k) NO: K203622(Traditional)
ATTN: Ting Jiang PHONE NO : 86 10 61252660
Valley No.1 Bio-medicine Industry SE DECISION MADE: 20-AUG-21
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enteral Extension Sets
GBUK Group Ltd 510(k) NO: K203633(Traditional)
ATTN: Lucy Islip PHONE NO : 017 572 88587
Blackwood Hall Business Park, NortSE DECISION MADE: 19-AUG-21
Selby GB YO85DD 510(k) STATEMENT
DEVICE: PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG
JKH USA, LLC 510(k) NO: K203636(Traditional)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
20505 Valley Blvd. Suite 108 SE DECISION MADE: 31-AUG-21
Walnut CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensatronic Reusable Temperature Probes
Sensatronic GmbH 510(k) NO: K203643(Traditional)
ATTN: Jens Schwarz PHONE NO : 49 3841 2252440
Am Ring 9 SE DECISION MADE: 11-AUG-21
Wismar DE 23970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nisus Touch Negative Pressure Wound Therapy Pump
Cork Medical Products, LLC 510(k) NO: K203693(Traditional)
ATTN: Patrick McGinley PHONE NO : 866 5512580
8000 Castleway Drive SE DECISION MADE: 13-AUG-21
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RBknee
Radiobotics ApS 510(k) NO: K203696(Traditional)
ATTN: Martin Christian Axelsen PHONE NO : 45 26 146184
Strandstrassde 21 4. th SE DECISION MADE: 27-AUG-21
Copenhagen DK DK1255 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
Careplus (M) SDN BHD 510(k) NO: K203705(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 6 06 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 20-AUG-21
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harmony Latex Dam, Harmony Non-Latex Dam
Pamco Distributing Inc. 510(k) NO: K203727(Traditional)
ATTN: Annette Maclean PHONE NO : 519 6482200
231 Arnold Street SE DECISION MADE: 05-AUG-21
Kitchener CA N2H 6E8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELAN 4 Electro Motor System
Aesculap Inc. 510(k) NO: K203739(Traditional)
ATTN: Kathy Racosky PHONE NO : 610 9847402
3773 Corporate Parkway SE DECISION MADE: 24-AUG-21
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM Premier 5000
Instrumentation Laboratory Co. 510(k) NO: K203790(Special)
ATTN: Gabriella Erdosy PHONE NO : 781 8614571
180 Hartwell Road SE DECISION MADE: 20-AUG-21
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical Anatomical Plating System
Tyber Medical LLC 510(k) NO: K203817(Traditional)
ATTN: Mark Schenk PHONE NO : 610 8490645
83 South Commerce Way SE DECISION MADE: 13-AUG-21
Bethlehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIVIX v1.1 Cervical Suction Tenaculum
Aspivix S.A. 510(k) NO: K203820(Traditional)
ATTN: Benjamin Klein PHONE NO : 40 0 763798797
Chemin du Closel SE DECISION MADE: 17-AUG-21
Renens CH 1020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stiletto Extended Dwell Catheter
Piper Access, LLC 510(k) NO: K210047(Traditional)
ATTN: Jay Muse PHONE NO : 801 2102886
6030 W. Harold Gatty Dr. SE DECISION MADE: 27-AUG-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impulse AM Interbody Fusion System
DeGen Medical 510(k) NO: K210090(Traditional)
ATTN: Craig Black PHONE NO : 843 9924551
1321-C North Cashua Drive SE DECISION MADE: 30-AUG-21
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
Osteonic Co., Ltd. 510(k) NO: K210122(Traditional)
ATTN: Da Kyung Ham PHONE NO : 82 2 69028456
39 Digital-ro 29-gil SE DECISION MADE: 27-AUG-21
Guro-gu KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ComfortGuard Surgical Isolation Gown
GRI-Alleset, Inc 510(k) NO: K210131(Traditional)
ATTN: Marty D Paugh PHONE NO : 678 5238977
4142 Industry Way SE DECISION MADE: 26-AUG-21
Flowery Branch GA 30542 510(k) STATEMENT
DEVICE: Deep Transcranial Magnetic Stimulation (DTMS) System
Brainsway Ltd. 510(k) NO: K210201(Traditional)
ATTN: Ahava Stein PHONE NO : 972 2 5283040
19 Hartom St. (Bynet Bldg) Har HotSE DECISION MADE: 17-AUG-21
Jerusalem IL 9777518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: mmRNA appliance
Vivos Therapeutics, Inc. (formerly510(k) NO: K210203(Abbreviated)
ATTN: Catheryn Bonar PHONE NO :
9137 S. Ridgeline Blvd. Suite 135 SE DECISION MADE: 19-AUG-21
Highland Ranch CO 80129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CiRx (R) Surgical Mask
Ningbo Shun Ye Medical Company, Lt510(k) NO: K210256(Traditional)
ATTN: Frank Yu PHONE NO : 011 86 5746377 8018
No.5 Industry Road, Zhangqi IndustSE DECISION MADE: 19-AUG-21
Ningbo CN 315313 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Manual Resuscitator
Xiamen Compower Medical Tech. Co.,510(k) NO: K210288(Traditional)
ATTN: Lifen Chen PHONE NO : 86 133 06000572__
Unit 301, No.16, Xianghong Road, XSE DECISION MADE: 26-AUG-21
Xiamen CN 361101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K210317(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 19-AUG-21
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K210318(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 18-AUG-21
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearCorrect System
ClearCorrect LLC 510(k) NO: K210320(Traditional)
ATTN: Christopher Klaczyk PHONE NO : 512 8315128
21 Cypress Boulevard, Suite 1010 SE DECISION MADE: 06-AUG-21
Round Rock TX 78665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
W.H.P.M., Inc. 510(k) NO: K210327(Traditional)
ATTN: John Wan PHONE NO : 626 4438480
5358 Irwindale Ave. SE DECISION MADE: 12-AUG-21
Irwindale CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Zirconia Implant System
JJGC Industria e Comercio de Mater510(k) NO: K210336(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 13-AUG-21
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bullfrog Micro-Infusion Device
Mercator MedSystems, Inc. 510(k) NO: K210339(Traditional)
ATTN: Kirk P. Seward PHONE NO : 510 6144550
1900 Powell Street Suite 800 SE DECISION MADE: 02-AUG-21
Emeryville CA 94608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean Pre-Milled Abutment
Dentis Co., Ltd. 510(k) NO: K210362(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 19-AUG-21
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Aligners
Shenzhen Yinuo Dental Technology C510(k) NO: K210373(Traditional)
ATTN: Mo Yuyum PHONE NO : 86 755 28761139
Xinfeng Industry Park No.11,101-30SE DECISION MADE: 27-AUG-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.V. Administration Set
BQ PLUS Medical Co., Ltd. 510(k) NO: K210381(Traditional)
ATTN: Jin Zhang PHONE NO : 86 21 57609106
No. 18, Cheye Road, Chedun Town, SSE DECISION MADE: 14-AUG-21
Shanghai CN 201611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adhesive Electrode
Shaoxing Yingtuo Healthcare Co.,Lt510(k) NO: K210448(Traditional)
ATTN: Haze XU PHONE NO : 86 137 35374377
NO.176 Shungeng Road,Baiguan StreeSE DECISION MADE: 31-AUG-21
Shaoxing CN 312300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auto Disable Syringe
Anhui Tiankang Medical Technology 510(k) NO: K210464(Traditional)
ATTN: Bai Baodong PHONE NO : 86 550 7309187
No.228 Weiyi Road, Economic DeveloSE DECISION MADE: 24-AUG-21
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo NXT ProVue Retriever
Stryker Neurovascular 510(k) NO: K210502(Traditional)
ATTN: Rebecca Rosman PHONE NO : 509 7104286
47900 Bayside Parkway SE DECISION MADE: 27-AUG-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown
Shandong Zhushi Pharmaceutical Gro510(k) NO: K210510(Traditional)
ATTN: Junhui Zhu PHONE NO : 86 530 7150111
No.6 Shande Road, Shan County SE DECISION MADE: 12-AUG-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXA-C Cervical Interbody System
Aurora Spine, Inc. 510(k) NO: K210521(Traditional)
ATTN: Laszlo Garamszegi PHONE NO : 760 4242004
1930 Palomar Point Way, Suite 103 SE DECISION MADE: 02-AUG-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOLF Thrombectomy System, 6F
DeVoro Medical, Inc. 510(k) NO: K210530(Traditional)
ATTN: Michael Wallace PHONE NO : 925 7849985
46724 Lakeview Blvd SE DECISION MADE: 27-AUG-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inset Reverse Total Shoulder System
Shoulder Innovations, Inc. 510(k) NO: K210533(Traditional)
ATTN: Don Running PHONE NO : 574 2531133
13827 Port Sheldon Street SE DECISION MADE: 20-AUG-21
Holland MI 49424 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ulrichINJECT CT motion
ulrich GmbH & Co. KG 510(k) NO: K210541(Traditional)
ATTN: Sven Erdmann PHONE NO : 49 731 96541714
Buchbrunnenweg 12 SE DECISION MADE: 06-AUG-21
Ulm DE 89081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Monopolar Laparoscopic Shafts and Reusable Handles
Dannik LLC 510(k) NO: K210569(Traditional)
ATTN: Olga Haberland PHONE NO : 407 9271743
941 W. Morse Blvd Suite 100 SE DECISION MADE: 16-AUG-21
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrimeTaper EV Dental Implant
Dentsply Sirona, Inc. 510(k) NO: K210610(Traditional)
ATTN: Karl J Nittinger PHONE NO : 717 4954286
221 West Philadelphia Street, SuitSE DECISION MADE: 27-AUG-21
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKR 3000
Konica Minolta, Inc. 510(k) NO: K210619(Traditional)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 24-AUG-21
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Shandong Zhushi Pharmaceutical Gro510(k) NO: K210643(Traditional)
ATTN: Junhui Zhu PHONE NO : 86 530 7150111
No.6 Shande Road, Shan County SE DECISION MADE: 04-AUG-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resection Electrodes with HF cable
Olympus Winter & Ibe GmbH 510(k) NO: K210651(Traditional)
ATTN: Katharina Campbell PHONE NO : 49 40 669662997
Kuehnstr. 61 SE DECISION MADE: 03-AUG-21
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
Quanta Dialysis Technologies Ltd 510(k) NO: K210661(Traditional)
ATTN: Sam Drew PHONE NO : 44 178 9400043
Tything Road SE DECISION MADE: 12-AUG-21
Alcester GB B49 6EU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
Weony (Shenzhen) Technology Co., L510(k) NO: K210671(Traditional)
ATTN: Autumn Liu PHONE NO : 86 755 86057437
3rd Floor B, Building 19, HeYi BeiSE DECISION MADE: 13-AUG-21
Shenzhen CN 518104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shoulder Pacemaker
NCS Lab Srl 510(k) NO: K210674(Traditional)
ATTN: Matteo Mantovani PHONE NO : 39 059 669813
Via Pola Esterna 4/12 SE DECISION MADE: 24-AUG-21
Carpi IT 41012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XSTAT 30 Pouch
RevMedx, Inc. 510(k) NO: K210676(Traditional)
ATTN: Amy K Pointer PHONE NO : 1 503 2707828
25999 SW Canyon Creek Road, Suite SE DECISION MADE: 27-AUG-21
Wilsonville OR 97070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K210680(Traditional)
ATTN: Sindhu Sridhar PHONE NO : 442 9997630
2210 Faraday Ave, Suite 100 SE DECISION MADE: 05-AUG-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR® NEXT ONE Blood Glucose Monitoring System
Ascensia Diabetes Care 510(k) NO: K210687(Special)
ATTN: Stacie Geffner-Atiya PHONE NO : 914 2668531
100 Summit Lake Drive SE DECISION MADE: 11-AUG-21
Valhalla NY 10595 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPM Medical Consultants Tibial Revision Knee System
CPM Medical Consultants, LLC. 510(k) NO: K210695(Traditional)
ATTN: Andy Rynearson PHONE NO : 321 3162601
1565 N. Central Expressway SE DECISION MADE: 16-AUG-21
Richardson TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECOMA Level 2 Disposable Surgical Mask with Ear Loops
Xianning Eco Medical Articles Co.,510(k) NO: K210698(Traditional)
ATTN: Wei Zhou PHONE NO : 86 715 8215222 8018
No.16,Shutai Street High-Tech InduSE DECISION MADE: 19-AUG-21
Xianning CN 437000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Careplus (M) SDN BHD 510(k) NO: K210724(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 606 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 03-AUG-21
Seremban MY 70450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Glove
PingAn Medical Products Co.,Ltd. 510(k) NO: K210725(Traditional)
ATTN: Zhou Ziyu PHONE NO : 86 199 31401105
Zheji Road, High-tech Industrial ZSE DECISION MADE: 06-AUG-21
Jiujiang CN 332500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Glove
American Performance Polymers, LLC510(k) NO: K210730(Traditional)
ATTN: Richard Renehan PHONE NO : 978 5268494
23 Gould Street SE DECISION MADE: 10-AUG-21
Colebrook NH 03576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heel Incision Safety Lancet
SteriLance Medical (Suzhou) Inc. 510(k) NO: K210745(Traditional)
ATTN: Yuan Jie PHONE NO : 86 512 65799308
No.168 PuTuoShan Road, New DistricSE DECISION MADE: 26-AUG-21
Suzhou CN 215153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Empty EVA Bag
Haemotronic S.p.a. 510(k) NO: K210749(Traditional)
ATTN: Franciosi Paola PHONE NO : 39 0535 619632
Via Carreri 16 SE DECISION MADE: 19-AUG-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solo, Swing Maxi
Medela LLC 510(k) NO: K210759(Traditional)
ATTN: Mike McAndrew PHONE NO : 1 815 5782376
1101 Corporate Drive SE DECISION MADE: 11-AUG-21
McHenry IL 60050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lateralized and Augmented Baseplates
FX Shoulder USA, Inc. 510(k) NO: K210790(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 25-AUG-21
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auxein Nailing System
Auxein Medical Private Limited 510(k) NO: K210792(Special)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No.168,169,170 Phase-IV, SectSE DECISION MADE: 25-AUG-21
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IO Expandable Lumbar Interbody Fusion System
MiRus, LLC 510(k) NO: K210800(Traditional)
ATTN: Jordan Bauman PHONE NO : 404 3458235
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 20-AUG-21
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceribell Instant EEG Headband
Ceribell, Inc. 510(k) NO: K210805(Traditional)
ATTN: Raymond Woo PHONE NO : 650 5564349
2483 Old Middlefield Way, Suite 12SE DECISION MADE: 30-AUG-21
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EAGLE EDGE AXR90 and AXR120
Alliage S/A Industrias Medico Odon510(k) NO: K210820(Abbreviated)
ATTN: Daniel Camargo PHONE NO : 55 16 35121212
Rod. Abrão Assed, Km 53+450m SE DECISION MADE: 10-AUG-21
Recreio Anhanguera BR 14097-500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROWLER SELECT PLUS; PROWLER EX
Medos International SARL 510(k) NO: K210838(Special)
ATTN: Samuel Shimp PHONE NO : 757 7909275
Chemin-Blanc 38 SE DECISION MADE: 25-AUG-21
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVent Eustachian Tube Dilation Balloon
Medtronic Xomed, Inc. 510(k) NO: K210841(Traditional)
ATTN: Matthew Harmon PHONE NO : 904 3326704
6743 Southpoint Drive North SE DECISION MADE: 16-AUG-21
Jacksonville FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DreamWear Silicone Pillows Mask
Respironics, Inc. 510(k) NO: K210844(Traditional)
ATTN: Steve Lawrie PHONE NO : 812 3690309
1740 Golden Mile Highway SE DECISION MADE: 24-AUG-21
Monroeville PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS Chemistry Products PHBR Slides
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K210858(Traditional)
ATTN: Darlene Phillips PHONE NO : 585 4099474
100 Indigo Creek Drive SE DECISION MADE: 13-AUG-21
Rochester NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Sochi OCT Spinal System
Altus Partners, LLC 510(k) NO: K210887(Traditional)
ATTN: Mark Melton PHONE NO :
1340 Enterprise Drive SE DECISION MADE: 20-AUG-21
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Shandong DS Safety Technology Co.,510(k) NO: K210897(Traditional)
ATTN: Summer Feng PHONE NO : 86 0536 2586046
West of Yaoqian Road, Yaogezhuang SE DECISION MADE: 24-AUG-21
Weifang CN 261502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
Tangshan Lanhai Medical Supplies C510(k) NO: K210898(Traditional)
ATTN: Li Ruidong PHONE NO : 86 159 31581811
South Side of Zhongda Street, EastSE DECISION MADE: 26-AUG-21
Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excelsius3D
Globus Medical Inc. 510(k) NO: K210912(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 12-AUG-21
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V12 PRO
SLK Medical GmbH 510(k) NO: K210913(Traditional)
ATTN: Matthew Reid PHONE NO : 49 163 7550203
Am Herdicksbach 18 SE DECISION MADE: 04-AUG-21
Waltrop DE 45731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elvie Stride
Chiaro Technology Limited 510(k) NO: K210936(Traditional)
ATTN: Carre King PHONE NO : 44 788 0363207
2nd Floor 63-66 Hatton Garden SE DECISION MADE: 25-AUG-21
London GB EC1N 8LE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
Promisemed Hangzhou Meditech Co., 510(k) NO: K210946(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 12-AUG-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kubtec Mozart (XPERT42)
KUB Technologies, Inc. 510(k) NO: K210956(Special)
ATTN: Chester Lowe PHONE NO : 203 3648544
111 Research Drive SE DECISION MADE: 31-AUG-21
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kubec Xpert 80 Radiography System
KUB Technologies, Inc. 510(k) NO: K210957(Special)
ATTN: Chester Lowe PHONE NO : 203 3648544
111 Research Drive SE DECISION MADE: 31-AUG-21
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K210958(Traditional)
ATTN: Maria Figueroa PHONE NO : 609 4549271
400 College Road East SE DECISION MADE: 13-AUG-21
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnteraLoc Flow
Vonco Products 510(k) NO: K210971(Traditional)
ATTN: Christie Marr PHONE NO : 262 2987203
10826 250th Avenue SE DECISION MADE: 18-AUG-21
Trevor WI 53179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
Guangdong Antmed Co., Ltd. 510(k) NO: K210991(Traditional)
ATTN: Zhiying Zhong PHONE NO : 86 769 82599182
Rm 201, Bld 3, Hualian Ave, SongshSE DECISION MADE: 26-AUG-21
Dongguan CN 523800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA Hip System
Orthosoft d/b/a Zimmer CAS 510(k) NO: K210998(Traditional)
ATTN: Paul Hardy PHONE NO : 574 4536739
75 Queen Street, Suite 3300 SE DECISION MADE: 17-AUG-21
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Minitube Dentasleeve Protective Barrier Sleeves
Minitube AB 510(k) NO: K211026(Traditional)
ATTN: Bengt Myhrman PHONE NO : 46 640 21900
Byvägen 44 SE DECISION MADE: 03-AUG-21
Trångsviken SE 83596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
Boston Scientific Corporation 510(k) NO: K211030(Traditional)
ATTN: Carter Navarro PHONE NO : 508 3820356
100 Boston Scientific Way SE DECISION MADE: 09-AUG-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681
Shenzhen Yuezhongxing Technology C510(k) NO: K211041(Traditional)
ATTN: Yuchao Chen PHONE NO : 86 135 10394198
No.2, Zhenye Road, Liulian CommuniSE DECISION MADE: 30-AUG-21
Shenzhen CN 518015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigon Medical Button System
Tigon Medical 510(k) NO: K211049(Traditional)
ATTN: Jeremy Clark PHONE NO : 410 5442833
838 Ritchie HWY, Suite 5 SE DECISION MADE: 04-AUG-21
Severna Park MD 21146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
Homtex, Inc. 510(k) NO: K211066(Abbreviated)
ATTN: Jeremy Wootten PHONE NO : 256 7343937
2125 2nd Avenue SW SE DECISION MADE: 19-AUG-21
Cullman AL 35055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrevisEA Device
Entac Medical Inc. 510(k) NO: K211068(Traditional)
ATTN: Buddy Lyons PHONE NO : 901 2923420
680 Oakleaf Office Lane, Suite 201SE DECISION MADE: 04-AUG-21
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Examination Gloves (Non-Sterile)
Jiangsu Cherish Medical Technology510(k) NO: K211075(Traditional)
ATTN: April Yao PHONE NO : 86 138 13656630
No. 55 Maqianan Chaoyang Road, JiaSE DECISION MADE: 05-AUG-21
Changzhou CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System
Abbott Diabetes Care, Inc. 510(k) NO: K211102(Traditional)
ATTN: Catherine Yang PHONE NO : 510 2069452
1360 South Loop Road SE DECISION MADE: 11-AUG-21
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
ConMed Corporation 510(k) NO: K211104(Traditional)
ATTN: Ally Xu PHONE NO : 720 6474626
525 French Road SE DECISION MADE: 19-AUG-21
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InferRead CT Stroke.AI
Infervision Medical Technology Co.510(k) NO: K211179(Traditional)
ATTN: Xiaoyan Fan PHONE NO : 86 138 10508664
Room B401, 4th Floor, Building 1, SE DECISION MADE: 12-AUG-21
Beijing CN 100085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H2H Powder Free Examination Blue Glove
NTL Innovation Co., Ltd. 510(k) NO: K211182(Traditional)
ATTN: Puttharaksa Sornkong PHONE NO : 66 0 748560012
68 Moo. 4 Chalung Subdistrict SE DECISION MADE: 01-AUG-21
Hatyai District TH 90110 510(k) STATEMENT
DEVICE: Molekule Air Pro
Molekule, Inc. 510(k) NO: K211194(Traditional)
ATTN: Frank Bianco PHONE NO : 925 4047724
1301 Folsom St. SE DECISION MADE: 20-AUG-21
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
Stryker 510(k) NO: K211202(Traditional)
ATTN: Jessie Duong PHONE NO : 408 8217952
5900 Optical Court SE DECISION MADE: 06-AUG-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prase-C Anterior Cervical Plate System
GBS Commonwealth Co., Ltd. 510(k) NO: K211205(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 12-AUG-21
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor NF0109
Adherium (NZ) Ltd 510(k) NO: K211233(Traditional)
ATTN: Chris Mander PHONE NO : 64 9 3072771
Level 11, 16 Kingston Street SE DECISION MADE: 18-AUG-21
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViperCross Support Catheters
Cardiovascular Systems, Inc. 510(k) NO: K211240(Traditional)
ATTN: Erika Huffman PHONE NO : 651 2591608
1225 Old Highway 8 NW SE DECISION MADE: 26-AUG-21
Saint Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Tianchang Kanghui Protective Produ510(k) NO: K211255(Traditional)
ATTN: Mark Wong PHONE NO : 86 015 255006789
No.16 Wayeconomic Development ZoneSE DECISION MADE: 28-AUG-21
Tianchan CN 293900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannulated Fasteners and Nuts
OsteoCentric Technologies 510(k) NO: K211290(Special)
ATTN: Todd Evans PHONE NO : 800 9690639
75 West 300 North, Suite #150 SE DECISION MADE: 03-AUG-21
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Link X2 ECG Cable and Leadwire System
Vyaire Medical, Inc. 510(k) NO: K211294(Traditional)
ATTN: Joshua Davis PHONE NO : 508 2940749
26125 North Riverwoods Blvd. SE DECISION MADE: 16-AUG-21
Mettawa IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CUBE 70
Alpinion Medical Systems Co., Ltd.510(k) NO: K211299(Traditional)
ATTN: Boyeon Cho PHONE NO : 82 70 74652104
5FL, I dong, 77, heungan-daero 81 SE DECISION MADE: 09-AUG-21
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CUBE 90
Alpinion Medical Systems Co., Ltd.510(k) NO: K211300(Traditional)
ATTN: Boyeon Cho PHONE NO : 82 70 74652104
5FL, I dong, 77, heungan-daero 81 SE DECISION MADE: 09-AUG-21
Anyang-si KR 14117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Purism Non-Sterile Powder Free Nitrile Examination Gloves
Dezhou Purism Medical Technology C510(k) NO: K211319(Traditional)
ATTN: Ting Luo PHONE NO : 86 188 09297845
High-end Equipment Manufacturing PSE DECISION MADE: 19-AUG-21
Dezhou CN 253100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paratrooper Plantar Plate Repair System
Paragon 28, Inc. 510(k) NO: K211322(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 30-AUG-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIDON FA, EIDON, EIDON AF, EIDON UWFL
CenterVue SpA 510(k) NO: K211328(Special)
ATTN: Luca Scienza PHONE NO : 39 049 5018399
Via S. Marco 9H SE DECISION MADE: 19-AUG-21
Padova IT 35129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves
ZHANGJIAGANG FENGYUAN PLASTIC PROD510(k) NO: K211351(Traditional)
ATTN: Huamei Wang PHONE NO : 86 1370 5111918
No.333,Fumin Middle Road,Tangqiao SE DECISION MADE: 13-AUG-21
Shangqiu CN 215615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Shenzhen Lyttop Healthcare Limited510(k) NO: K211353(Traditional)
ATTN: Lily Wu PHONE NO : 86 0755 22951616
A201, building 7, Dongjiu innovatiSE DECISION MADE: 11-AUG-21
Shenzhen CN 518114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Synthetic Vinyl Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K211354(Traditional)
ATTN: Guo Hua PHONE NO : 86 1348 5097856
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 08-AUG-21
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCAR 3
EL. En Electronic Engineering SPA 510(k) NO: K211362(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 25-AUG-21
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software
Siemens Medical Solutions USA, Inc510(k) NO: K211373(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 27-AUG-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARband
Orthomerica Products Inc. 510(k) NO: K211376(Special)
ATTN: David C. Kerr PHONE NO : 407 2906592
6333 North Orange Blossom Trail SE DECISION MADE: 17-AUG-21
Orlando FL 32810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NFLK-2501 Portable X-ray Unit
NEUF Inc. 510(k) NO: K211383(Traditional)
ATTN: Woo Sang Lee PHONE NO : 82 61 7402830
#103 Production Bldg. 13, YulchonsSE DECISION MADE: 13-AUG-21
Jeollanam-do KR 58034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lateral Spine Truss System (LSTS) Interbody Fusion Device
4WEB Medical, Inc. 510(k) NO: K211388(Special)
ATTN: Lewis Harrison PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 05-AUG-21
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Blue Powder-free Examination Glove
Cardinal Health 200, LLC 510(k) NO: K211390(Traditional)
ATTN: William Cisneros PHONE NO : 614 6521441
3651 Birchwood Drive SE DECISION MADE: 28-AUG-21
Waukegan IL 60085 510(k) STATEMENT
DEVICE: BEE PLIF Cage
NGMedical GmbH 510(k) NO: K211413(Traditional)
ATTN: Stella Hahn PHONE NO : 49 6873 99997100
Talsperrenblick 5 SE DECISION MADE: 27-AUG-21
Nonnweiler DE 66620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KHEIRON Spinal Fixation System
S. M. A. I. O 510(k) NO: K211414(Traditional)
ATTN: Jean-Charles Roussouly PHONE NO : 33 67 0165171
2, Place Berthe Morisot Parc TechnSE DECISION MADE: 10-AUG-21
Saint-Priest FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: breastscape v1.0
Olea Medical 510(k) NO: K211431(Traditional)
ATTN: Nathalie Palumbo PHONE NO : 33 4 42712420
93 Avenue des Sorbiers, ZI ATHELIASE DECISION MADE: 02-AUG-21
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves
Zhangjiagang Huayuan Protective Eq510(k) NO: K211434(Traditional)
ATTN: Huamei Wang PHONE NO : 86 137 05111918
No.333, Fumin Middle Road, TangqiaSE DECISION MADE: 05-AUG-21
Zhangjiagang CN 215615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAO Cortical Screw
Medacta International SA 510(k) NO: K211435(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 06-AUG-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CellFX System
Pulse Biosciences, Inc. 510(k) NO: K211444(Traditional)
ATTN: Punam Gollamudi PHONE NO : 415 3054404
3957 Point Eden Way SE DECISION MADE: 25-AUG-21
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triton™ Sacroiliac Joint Fixation System
ChoiceSpine, LLC 510(k) NO: K211449(Traditional)
ATTN: Kim Finch PHONE NO : 865 2433375
400 Erin Drive SE DECISION MADE: 31-AUG-21
Knoxville TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask (non sterile)
Qinhuangdao Taizhi Medical Technol510(k) NO: K211451(Traditional)
ATTN: Fan Xifan PHONE NO : 86 133 83659307
No.5, Small and Medium EnterprisesSE DECISION MADE: 25-AUG-21
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical mask
Jiangsu Xingtong Biotechnology Gro510(k) NO: K211454(Traditional)
ATTN: Li Hua PHONE NO : 86 0514 87485222
No.8, Kele road, Touqiao Area, BeiSE DECISION MADE: 18-AUG-21
Yangzhou CN 225000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
Xiantao S&J Protective Products Co510(k) NO: K211462(Traditional)
ATTN: Dove Wei PHONE NO : 86 186 72857899
103 Mianyang Road SE DECISION MADE: 19-AUG-21
Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO 600 Medium Steam Sterilizer
Steris Corporation 510(k) NO: K211500(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 25-AUG-21
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantage-C PEEK Cervical lnterbody Fusion Device
lntelivation, LLC 510(k) NO: K211501(Traditional)
ATTN: Jack Griffis PHONE NO : 404 5836889
70 Gruber Lane SE DECISION MADE: 24-AUG-21
Saint Simons Island GA 31522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alpha Vent PEEK Suture Anchor
Stryker Endoscopy 510(k) NO: K211502(Traditional)
ATTN: Christie Samsa PHONE NO : 978 5001303
5900 Optical Ct. SE DECISION MADE: 04-AUG-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: sam X1 Long Duration Ultrasound Device
ZetrOZ Systems, LLC 510(k) NO: K211513(Special)
ATTN: Sabrina Lewis PHONE NO : 888 2029831___
56 Quarry Road SE DECISION MADE: 18-AUG-21
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Beijing Reagent Latex Products Co.510(k) NO: K211515(Abbreviated)
ATTN: HaiTao Liu PHONE NO : 86 10 81502524
No. 6 Xingguang 5th Street, Opto-MSE DECISION MADE: 24-AUG-21
Beijing CN 101111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Nitrile Synthetic Gloves Powder Free
Tangshan Hongyun Plastic Products 510(k) NO: K211516(Traditional)
ATTN: Suying Le PHONE NO : 86 139 33365259
South Shenggezhuang Village,PachigSE DECISION MADE: 24-AUG-21
Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Every Cycle Reusable Tampon Applicator
Cycle, LLC 510(k) NO: K211519(Traditional)
ATTN: Jessica Samson PHONE NO : 949 2949724
1927 Washington Avenue SE DECISION MADE: 13-AUG-21
Santa Monica CA 90403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E10s, LOGIQ Fortis
GE Healthcare 510(k) NO: K211524(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 27-AUG-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exo Iris
Exo Imaging Inc. 510(k) NO: K211527(Traditional)
ATTN: Antoanela Gomard PHONE NO : 650 2830458
3600 Bridge Parkway Suite 102 SE DECISION MADE: 20-AUG-21
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edma Synthetic Nitrile Examination Gloves
Edma Group, LLC 510(k) NO: K211540(Traditional)
ATTN: Vio Cretu PHONE NO :
3634 E Piccadilly Rd SE DECISION MADE: 09-AUG-21
Phoenix AZ 85018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wishbone HA
Wishbone SA 510(k) NO: K211551(Traditional)
ATTN: Emilie Dory PHONE NO : 32 484 706172
1, Rue de 1'Expansion SE DECISION MADE: 20-AUG-21
Flemalle BE 4400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical mask
Shandong Shengquan New Materials C510(k) NO: K211552(Traditional)
ATTN: Xiumei Zhang PHONE NO : 86 138 64136816
Diaozhen Industrial Development ZoSE DECISION MADE: 11-AUG-21
Jinan CN 250204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tecomet Global Unite Short Stem Instrumentation
Symmetry Medical Manufacturing Inc510(k) NO: K211553(Traditional)
ATTN: Mike Parrish PHONE NO : 574 2678700
3724 North State Road 15 SE DECISION MADE: 04-AUG-21
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pitch-Patchs
Xiros Ltd 510(k) NO: K211563(Traditional)
ATTN: Steve Curran PHONE NO : 44 113 2387200
Springfield House Lane, WhitehouseSE DECISION MADE: 13-AUG-21
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Insulet Corporation 510(k) NO: K211575(Traditional)
ATTN: Dennis Shay PHONE NO : 978 8461247
100 Nagog Park SE DECISION MADE: 13-AUG-21
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WYZ Surgical Mask
WYZ Medical Supplies LLC 510(k) NO: K211576(Traditional)
ATTN: Daniel Chen PHONE NO : 1 512 9427893
5913 Imperial Loop SE DECISION MADE: 19-AUG-21
College Station TX 77845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral Surgery Contra
Nakanishi INC. 510(k) NO: K211584(Traditional)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohinata SE DECISION MADE: 19-AUG-21
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caretaker Platform, VitalStream Platform, CT5
Caretaker Medical 510(k) NO: K211588(Special)
ATTN: Jeff Pompeo PHONE NO : 434 9787000
941 Glenwood Station Ln #301 SE DECISION MADE: 13-AUG-21
Charlottesville VA 22901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K211608(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 05-AUG-21
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
DePuy Ireland UC 510(k) NO: K211609(Traditional)
ATTN: Brad Osborne PHONE NO : 574 4043872
Loughbeg SE DECISION MADE: 25-AUG-21
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExcelsiusHub
Globus Medical Inc. 510(k) NO: K211616(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 25-AUG-21
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
Shen Wei USA Inc. 510(k) NO: K211620(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 19-AUG-21
Union City CA 94587 510(k) STATEMENT
DEVICE: VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
bioMerieux, Inc 510(k) NO: K211630(Traditional)
ATTN: Mary Beth Anheuser PHONE NO : 618 6673179
595 Anglum Rd. SE DECISION MADE: 30-AUG-21
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Macheng Thimble Technology Investm510(k) NO: K211631(Traditional)
ATTN: Donghong Sheng PHONE NO : 86 139 10635968
Xiling 2nd Road, Douposhan VillageSE DECISION MADE: 18-AUG-21
Huanggang CN 438000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hypodermic Needle-Pro EDGE Safety Device
Smiths Medical ASD, Inc. 510(k) NO: K211634(Special)
ATTN: Dominique Neisz PHONE NO : 763 3833059
6000 Nathan Lane North SE DECISION MADE: 26-AUG-21
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ponto 5 Mini
Oticon Medical AB 510(k) NO: K211640(Special)
ATTN: Anja Ravn PHONE NO : 45 26 774422
Datavagen 37B SE DECISION MADE: 10-AUG-21
Askim SE SE-436 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System (Reperfusion Catheter RED 72)
Penumbra, Inc. 510(k) NO: K211654(Traditional)
ATTN: Nikita Patel PHONE NO : 408 8231820
One Penumbra Place SE DECISION MADE: 16-AUG-21
Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPHASYS Femoral Stems
DePuy Ireland UC 510(k) NO: K211657(Traditional)
ATTN: Erin Combs PHONE NO : 574 4048348
SE DECISION MADE: 05-AUG-21
Loughbeg IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Journey II Mid-Level Tibial Inserts
Smith & Nephew, Inc. 510(k) NO: K211671(Special)
ATTN: Kayla Franklin PHONE NO : 901 3252471
1450 East Brooks Rd SE DECISION MADE: 17-AUG-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Given Imaging Ltd. (Medtronic) 510(k) NO: K211684(Traditional)
ATTN: Efrat Shamgar PHONE NO : 972 73 2501577
2 Hacarmel St. New Industrial ParkSE DECISION MADE: 27-AUG-21
Yoqneam IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Exam Gloves, Powder Free, Blue
Hengchang (Dongying) Medical Techn510(k) NO: K211699(Traditional)
ATTN: Li Jing PHONE NO : 86 18 653343268
Room 101, Building 2, No.26 XingheSE DECISION MADE: 20-AUG-21
Dongying CN 510(k) STATEMENT
DEVICE: Insignia Hip Stem
Stryker Orthopaedics 510(k) NO: K211703(Traditional)
ATTN: Valerie Giambanco PHONE NO : 201 6696630
325 Corporate Drive SE DECISION MADE: 16-AUG-21
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
Orthofix Inc. 510(k) NO: K211704(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 31-AUG-21
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Nitrile Gloves
Jiangsu Health-Peace Medical Techn510(k) NO: K211708(Traditional)
ATTN: Min Liu PHONE NO : 61 401 589995
DongAn Youdian Street, Huangli TowSE DECISION MADE: 17-AUG-21
Changzhou CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
Hengchang (Dongying) Medical Techn510(k) NO: K211714(Traditional)
ATTN: Li Jing PHONE NO : 86 186 53343268
Room 101,Building 2,No.26 Xinghe RSE DECISION MADE: 04-AUG-21
Dongying CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senographe Pristina
GE Healthcare 510(k) NO: K211725(Traditional)
ATTN: Barthelemy Arman PHONE NO : 33 130 704040
283 Rue de la Miniere SE DECISION MADE: 06-AUG-21
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplify Disc
NuVasive, Inc. 510(k) NO: K211757(Traditional)
ATTN: Beth Neil PHONE NO : 404 6249474
685 North Pastoria Avenue SE DECISION MADE: 20-AUG-21
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
Hartalega Ngc Sdn. Bhd. 510(k) NO: K211758(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 62771733
No.1 Persiaran Tanjung SE DECISION MADE: 03-AUG-21
Sepang MY 43900 510(k) STATEMENT
DEVICE: Vereos PET/CT
Philips Medical Systems Nederland 510(k) NO: K211764(Traditional)
ATTN: Carmit Shmuel PHONE NO : 972 542109054
Veenpluis 6 SE DECISION MADE: 06-AUG-21
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCO FP-S
A.T.S. Applicazione Tecnologie Spe510(k) NO: K211777(Traditional)
ATTN: Livia Pillitteri PHONE NO : 39 035 584311
Via Alessandro Volta, 10 SE DECISION MADE: 13-AUG-21
Torre De Roveri IT 24060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriMed Threaded Intramedullary Nail System
TriMed, Inc. 510(k) NO: K211783(Traditional)
ATTN: David Medoff PHONE NO : 661 2557406
27533 Avenue Hopkins SE DECISION MADE: 06-AUG-21
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc. 510(k) NO: K211784(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 06-AUG-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ez3D-i/E3
Ewoosoft Co., Ltd 510(k) NO: K211791(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 20-AUG-21
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzOrtho
Ewoosoft Co., Ltd 510(k) NO: K211793(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 23-AUG-21
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodentine XP 500, Biodentine XP 200
Septodont 510(k) NO: K211799(Traditional)
ATTN: Kimty Bui-Van PHONE NO : 331 49 767116
58, rue du Pont De Creteil SE DECISION MADE: 10-AUG-21
Saint-Maur des Fosses Cedex FR 94510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
Venclose, Inc. 510(k) NO: K211806(Traditional)
ATTN: Mai-Ly Wilcox PHONE NO : 415 2541930
2570 N. 1st Street, FL 2, #221 SE DECISION MADE: 03-AUG-21
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triton
Inter-Med / Vista Dental 510(k) NO: K211813(Special)
ATTN: Brett Arand PHONE NO : 262 6315313
2200 South Street SE DECISION MADE: 18-AUG-21
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Bipolar Generator USG-410 with accessories
Olympus Medical Systems Corporatio510(k) NO: K211838(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 04-AUG-21
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Discovery MI Gen2
GE Medical Systems, LLC. 510(k) NO: K211846(Traditional)
ATTN: Laura Turner PHONE NO : 262 2001044
3000 North Grandview Blvd SE DECISION MADE: 20-AUG-21
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
Anhui Powerguard Technology Co., L510(k) NO: K211860(Traditional)
ATTN: Nick Dai PHONE NO : 86 557 6868999
Lingbi Economic Development Zone (SE DECISION MADE: 13-AUG-21
Suzhou CN 234200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eVolve PACS
eVolve PACS Inc. 510(k) NO: K211863(Traditional)
ATTN: David Donahue PHONE NO : 972 5677300
3924 Bryn Mawr Drive SE DECISION MADE: 12-AUG-21
Dallas TX 75225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSX Interbody System
Alphatec Spine, Inc. 510(k) NO: K211873(Traditional)
ATTN: Cynthia Dorne PHONE NO : 760 4946740
1950 Camino Vida Roble SE DECISION MADE: 10-AUG-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM® Patient Specific Instrumentation (PSI) System
In2Bones SAS 510(k) NO: K211883(Traditional)
ATTN: Morgane Grenier PHONE NO : 33 4 72292626
26 Chemin du Petit Bois SE DECISION MADE: 11-AUG-21
Ecully FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SelectFlex Neurovascular Access System Family
Q'Apel Medical Inc 510(k) NO: K211893(Special)
ATTN: Ken Peartree PHONE NO : 510 7386255
46708 Lakeview Boulevard SE DECISION MADE: 05-AUG-21
Fremont AR 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BC Reflex Uni Knee System
Bodycad Laboratories, Inc. 510(k) NO: K211895(Traditional)
ATTN: Nadine Adia PHONE NO : 418 527 1388
2035, rue du Haut-Bord SE DECISION MADE: 20-AUG-21
Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Zhejiang Hongyu Medicali Commodity510(k) NO: K211897(Traditional)
ATTN: Sophie Sophie PHONE NO : 86 0579 85980762
668 ChanHua Road, Fotang Town InduSE DECISION MADE: 03-AUG-21
Yiwu CN 322002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shoreline Threaded TruProfile® Plate
SeaSpine Orthopedics Corporation 510(k) NO: K211903(Traditional)
ATTN: Kavita Chandrashekar PHONE NO : 858 4051276
5770 Armada Drive SE DECISION MADE: 30-AUG-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPS e.max One
Ivoclar Vivadent AG 510(k) NO: K211916(Traditional)
ATTN: Sandra Cakebread PHONE NO : 423 235 3535
Bendererstrasse 2 SE DECISION MADE: 20-AUG-21
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
Globus Medical Inc. 510(k) NO: K211957(Traditional)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 18-AUG-21
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMM Ultrasonic Transducer Cover
Exact Medical Manufacturing 510(k) NO: K211969(Third Party - Traditional)
ATTN: Ryan Power PHONE NO : 716 6810866
4917 William Street - Suite C SE DECISION MADE: 13-AUG-21
Lancaster NY 14086 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Z-LINKPC System
Zavation Medical Products LLC 510(k) NO: K211993(Traditional)
ATTN: Colby Williams PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 11-AUG-21
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonendo Filling Material 5C
Sonendo, Inc. 510(k) NO: K211995(Traditional)
ATTN: Steve Ziemba PHONE NO : 909 4371630
26061 Merit Circle, Suite 102 SE DECISION MADE: 27-AUG-21
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyoSPECT, MyoSpect ES
GE Healthcare 510(k) NO: K212004(Traditional)
ATTN: George Mashour PHONE NO : 972 4 8563666 639
4 Hayozma Street SE DECISION MADE: 27-AUG-21
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTICALE Navigation Instruments
Silony Medical GmbH 510(k) NO: K212007(Traditional)
ATTN: Ralf Klabunde PHONE NO : 49 0 7117825250
Leinfelder StraBe 60 SE DECISION MADE: 12-AUG-21
Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Virage Navigation System
Zimmer Biomet Spine, Inc. 510(k) NO: K212023(Traditional)
ATTN: David Pollard PHONE NO : 303 2530056
10225 Westmoor Drive SE DECISION MADE: 27-AUG-21
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TurboHawk Plus Directional Atherectomy System
Medtronic, Inc 510(k) NO: K212027(Traditional)
ATTN: Jenny Andersen PHONE NO : 763 5913010
4600 Nathan Lane North SE DECISION MADE: 24-AUG-21
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K&J Consulting Corporation 510(k) NO: K212038(Traditional)
ATTN: Barry E. Sands PHONE NO : 978 3587307
2260 Glenview dr SE DECISION MADE: 27-AUG-21
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAREON MONARCH IV IOL Delivery System
ALCON LABORATORIES, INC. 510(k) NO: K212039(Traditional)
ATTN: Jwalitha Shankardas PHONE NO : 817 5518582
6201 South Freeway SE DECISION MADE: 23-AUG-21
Fort Worth TX 76134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
Intuitive Surgical, Inc. 510(k) NO: K212048(Traditional)
ATTN: Jennifer Siu PHONE NO : 408 5235372
1266 Kifer Road SE DECISION MADE: 26-AUG-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RFA-1717DIG, RFA-1717DIC
ASTEL Inc. 510(k) NO: K212051(Traditional)
ATTN: Yonghwan Jeon PHONE NO : 82 42 3602100
26-79, Gajeongbuk-ro, Yuseong-gu SE DECISION MADE: 25-AUG-21
Daejeon KR 34113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
Asensus Surgical, Inc. 510(k) NO: K212054(Traditional)
ATTN: Taylor Fisher PHONE NO : 1 919 7658459
1 TW Alexander Drive, Suite 160 SE DECISION MADE: 30-AUG-21
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K212056(Traditional)
ATTN: Janine F. Reyes PHONE NO : 714 7301310
1385 Shimoshigami SE DECISION MADE: 04-AUG-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adena-Zina System
Shanghai Sanyou Medical Co, LTD 510(k) NO: K212066(Traditional)
ATTN: David Fan PHONE NO : 86 21 58389980__
385 Huirong Road SE DECISION MADE: 16-AUG-21
Jiading District CN 201815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMTI S141 Lumbar Interbody Fusion System
Kyocera Medical Technologies, Inc.510(k) NO: K212070(Special)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1200 California St, Suite 210 SE DECISION MADE: 30-AUG-21
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tactoset Injectable Bone Substitute
Anika Therapeutics. Inc. 510(k) NO: K212083(Traditional)
ATTN: Wei Zhao PHONE NO : 978 8885948
32 Wiggins Avenue SE DECISION MADE: 31-AUG-21
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable medical surgical mask
Hebei Titans Hongsen Medical Techn510(k) NO: K212097(Traditional)
ATTN: Chai Wu PHONE NO : 86 177 69045117
Eastern Industrial Concentration ZSE DECISION MADE: 18-AUG-21
Xingtai CN 055750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kosmos
EchoNous, Inc. 510(k) NO: K212100(Third Party - Traditional)
ATTN: Carly Hom PHONE NO : 602 3155728
8310 154th Ave NE, Building B, SuiSE DECISION MADE: 06-AUG-21
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
FONA S.r.l 510(k) NO: K212103(Traditional)
ATTN: Luigi Germano PHONE NO : 39 02 45712171
Via G.Galilei 11 SE DECISION MADE: 30-AUG-21
Assago IT 20057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
PZMedical Technology Co., Ltd. 510(k) NO: K212105(Traditional)
ATTN: Peter Yixin Li PHONE NO : 86 021 60136588
5F, Building 13 No. 2 Suide Road, SE DECISION MADE: 23-AUG-21
Shanghai CN 200331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Relivion
Neurolief Ltd. 510(k) NO: K212106(Special)
ATTN: Michal Kedar-Datel PHONE NO : 972 9 3730288
12 Giborei Israel St. SE DECISION MADE: 02-AUG-21
Netanya IL 4250412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diagnostic X-ray System/PLX5200A
Nanjing Perlove Medical Equipment 510(k) NO: K212134(Traditional)
ATTN: Lu Fengfang PHONE NO : 86 025 68571666
No.97&99, Wangxi Road, Jiangning DSE DECISION MADE: 25-AUG-21
Nanjing CN 211100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remex KA6
Remedi Co. Ltd. 510(k) NO: K212144(Traditional)
ATTN: Suho Cho PHONE NO : 820 02 21355889
#1409, IS BIZ Tower, 26 YangpyeongSE DECISION MADE: 03-AUG-21
Seoul KR 072NN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR 800 with DSA, DR 800
Agfa N.V. 510(k) NO: K212145(Traditional)
ATTN: Wim Govaerts PHONE NO : 32 3 4446246
Septestraat 27 SE DECISION MADE: 31-AUG-21
Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynaCAD
Invivo Corporation 510(k) NO: K212175(Third Party - Abbreviated)
ATTN: Liselotte Kornmann PHONE NO : 316 11621238
3545 SW 47th Ave SE DECISION MADE: 02-AUG-21
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Golden Isles Pedicle Screw System
Intelivation LLC 510(k) NO: K212185(Traditional)
ATTN: Amit Sinha PHONE NO : 484 3433075
70 Gruber Lane SE DECISION MADE: 19-AUG-21
Saint Simons Island GA 31522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
CD Diagnostics Inc 510(k) NO: K212204(Special)
ATTN: Pragnya Bakka PHONE NO : 973 3078038
650 Naamans Road Suite 100 SE DECISION MADE: 11-AUG-21
Claymont DE 19703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jot Dx Insertable Cardiac Monitor
Abbott (St. Jude Medical) 510(k) NO: K212206(Special)
ATTN: Juni Sarkar PHONE NO : 818 2943429
15900 Valley View Ct. SE DECISION MADE: 13-AUG-21
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATCHMAN FXD Curve Access System
Boston Scientific Corporation 510(k) NO: K212228(Special)
ATTN: Alexa M. Keenan PHONE NO : 763 4941731
Three Scimed Place SE DECISION MADE: 13-AUG-21
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: White Endoseal MTA
MARUCHI 510(k) NO: K212229(Special)
ATTN: Jang Sung Wook PHONE NO : 82 33 7340330
2-208, Medical Industry Complex BlSE DECISION MADE: 13-AUG-21
Wonju-si KR 26311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruSPECT Radiological Image Processing Station
Spectrum Dynamics Medical Ltd 510(k) NO: K212230(Special)
ATTN: Igor Naroditsky PHONE NO : 972 54 4384386
22 Bareket St North Industrial ParSE DECISION MADE: 16-AUG-21
Caesarea IL 3079837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethos Treatment Management, Ethos Treatment Planning
Varian Medical Systems, Inc. 510(k) NO: K212294(Special)
ATTN: Peter J. Coronado PHONE NO : 1 650 4246320
911 Hansen Way SE DECISION MADE: 20-AUG-21
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
FUJIFILM Corporation 510(k) NO: K212296(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 19-AUG-21
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omni Foot and Ankle Plating System
Extremity Medical, LLC. 510(k) NO: K212297(Special)
ATTN: Brian Smekal PHONE NO : 973 5888988
300 Interpace Parkway, Suite 410 SE DECISION MADE: 20-AUG-21
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Callaly Tampliner (super plus absorbency)
Calla Lily Personal Care, Ltd. 510(k) NO: K212304(Special)
ATTN: Shaun Knights PHONE NO : 447 592 694078
10 Rose & Crown Yard SE DECISION MADE: 19-AUG-21
London GB SW1Y 6RE 510(k) STATEMENT
DEVICE: Cellvizio I.V.E. system with Confocal Miniprobes
Mauna Kea Technologies 510(k) NO: K212322(Special)
ATTN: Aline Criton PHONE NO : 33 1700 80994
9 Rue d'Enghien SE DECISION MADE: 18-AUG-21
Paris FR 75010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instinct Plus Endoscopic Clipping Device
Wilson-Cook Medical Inc. 510(k) NO: K212323(Special)
ATTN: Scottie Fariole PHONE NO : 336 7440157
4900 Bethania Station Road SE DECISION MADE: 25-AUG-21
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RenovoCath
RenovoRx, Inc. 510(k) NO: K212324(Special)
ATTN: Debra Cogan PHONE NO : 650 2844433
4546 El Camino Real, Suite B1 SE DECISION MADE: 23-AUG-21
Los Altos CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K212345(Special)
ATTN: Sindhu Sridhar PHONE NO : 442 9997630
2210 Faraday Ave, Suite 100 SE DECISION MADE: 27-AUG-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
Checkpoint Surgical 510(k) NO: K212355(Special)
ATTN: Ben Cottrill PHONE NO : 216 3789107
6050 Oak Tree Blvd., Suite 360 SE DECISION MADE: 26-AUG-21
Independence OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMRIS iMRI 3T V
Deerfield Imaging, Inc. 510(k) NO: K212367(Third Party - Traditional)
ATTN: Tacy Brinkmeyer PHONE NO : 612 4126330
5101 Shady Oak Rd SE DECISION MADE: 23-AUG-21
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EndoNaut
Therenva SAS 510(k) NO: K212383(Special)
ATTN: Audrey Gallois PHONE NO : 00 33972 522921
74F rue de Paris SE DECISION MADE: 31-AUG-21
Rennes FR 35000 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 286
TOTAL WITH SUMMARIES 272
TOTAL WITH STATEMENTS 14
