510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2020
DEVICE: High-speed air turbine handpiece / Low-speed air turbine handpiece
Foshan Wenjian Medical Instrument 510(k) NO: K181691(Traditional)
ATTN: Wen Huang PHONE NO : 86 757 81801258
Third Floor, No. 3, Jiebian IndustSE DECISION MADE: 26-MAY-20
Foshan CN 528225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIVIA
LifeCare Ltd. 510(k) NO: K183110(Traditional)
ATTN: Amnon Nahum Sharon PHONE NO : 972 4 6716020 40
Zipori St.2 SE DECISION MADE: 04-MAY-20
Tiberias IL 1424602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K190118(Traditional)
ATTN: Sammy Li PHONE NO : 86 020 66393598
23 Building, Phase-II Huachuang InSE DECISION MADE: 13-MAY-20
Panyu CN 511400 510(k) STATEMENT
DEVICE: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
AngioDynamics, Inc. 510(k) NO: K190559(Traditional)
ATTN: Vidyalakshmi Jayaraman PHONE NO : 508 6587925
26 Forest Street SE DECISION MADE: 22-MAY-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Digital Blood Pressure Monitor
Xiamen Ants Bro Technology Co., Lt510(k) NO: K190982(Traditional)
ATTN: Jane Xu PHONE NO : 86 13 459020349
4th & 5th Floor, No.5 Building, TeSE DECISION MADE: 29-MAY-20
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
MATIA Robotics (US) Inc 510(k) NO: K191334(Traditional)
ATTN: Necati Hacikadiroglu PHONE NO : 801 9971812
1929 S 4130 W, Unit A SE DECISION MADE: 29-MAY-20
Salt Lake City UT 84104 510(k) STATEMENT
DEVICE: LifeFlow Blood System
410 Medical, Inc. 510(k) NO: K191362(Traditional)
ATTN: Galen Robertson PHONE NO : 844 4355450
201 West Main Street, Suite 207 SE DECISION MADE: 20-MAY-20
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LotusCatheter (Lotus No Balloon Catheter)
Hakki Medical Technologies, Inc. 510(k) NO: K191512(Traditional)
ATTN: Shereen Said Hakky PHONE NO : 727 4157448
10333 Seminole Boulevard, Suite #8SE DECISION MADE: 21-MAY-20
Largo FL 33778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AA temp temporary restoration 3D printing photoreactive resin
Enlighten Materials Co., Ltd 510(k) NO: K191590(Traditional)
ATTN: Jiun Ming Su PHONE NO : 886 886 956973958
8F., NO.138, Sec.2, Jinshan S. Rd.SE DECISION MADE: 05-MAY-20
Taipei TW 10642 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Commander Flex
Medtronic Care Management Services510(k) NO: K191745(Traditional)
ATTN: Gordon Nelson PHONE NO : 952 4436329
7980 Century Boulevard SE DECISION MADE: 15-MAY-20
Chanhassan MN 55317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
Winner Medical Co., Ltd. 510(k) NO: K191819(Traditional)
ATTN: Dan Wang PHONE NO : 86 755 28138888
Winner Industrial Park, No. 660 BuSE DECISION MADE: 14-MAY-20
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KeYi Total Hip System
Beijing KeYi Medical Device Techno510(k) NO: K191826(Traditional)
ATTN: Jenny Jiang PHONE NO : 86 10 67853877
Building 1, 30 Yongchang South RoaSE DECISION MADE: 14-MAY-20
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps
Adeor Medical AG 510(k) NO: K191847(Traditional)
ATTN: Florian Gehrmann PHONE NO : 49 089 74442398
Biberger Str. 93 SE DECISION MADE: 22-MAY-20
Unterhaching DE 82008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
MiRus, LLC 510(k) NO: K191906(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway SE DECISION MADE: 18-MAY-20
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOV O10
Alber GmbH 510(k) NO: K192016(Traditional)
ATTN: Michael Vent PHONE NO : 49 30 31804530
Vor dem Weißen Stein 21 SE DECISION MADE: 19-MAY-20
Albstadt DE 72461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Endoscope Valves Set
Anrei Medical (Hangzhou) Co., Ltd.510(k) NO: K192048(Traditional)
ATTN: Yang HuiBing PHONE NO : 86 571 8691333 8658
No. 3 Ave 8, HEDA SE DECISION MADE: 14-MAY-20
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aerodentis System
Dror Orthodesign 510(k) NO: K192069(Traditional)
ATTN: Michael Nadav PHONE NO : 972 74 7006700
7 Hartom St., Mount Hotzvim SE DECISION MADE: 06-MAY-20
Jerusalem IL 9777507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thunderbeat Open Fine Jaw Type X Hand Instrument
Olympus Medical Systems Corp. 510(k) NO: K192103(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 426 422694
2951 Ishikawa-cho SE DECISION MADE: 11-MAY-20
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral/Enteral Syringe
Shanghai Kindly Enterprise Develop510(k) NO: K192179(Traditional)
ATTN: Weixin Zhang PHONE NO : 86 21591 16715
No. 658 Gaochao Road SE DECISION MADE: 01-MAY-20
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
Fresenius Medical Care Renal Thera510(k) NO: K192209(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 08-MAY-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Custom Legacy and Custom InterActive Titanium Abutments
Implant Direct Sybron Manufacturin510(k) NO: K192218(Traditional)
ATTN: Reina Choi PHONE NO : 818 4443306
3050 East Hillcrest Drive SE DECISION MADE: 08-MAY-20
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-Inject Single use Needle
POONGLIM Pharmatech Inc. 510(k) NO: K192222(Traditional)
ATTN: Cho Hee Min PHONE NO : 82 63451 8141
21, Jayumuyeok 1-gil SE DECISION MADE: 12-MAY-20
Gunsan-Si KR 54001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arcad SmileStudio and Aligner System
ArcadLab 510(k) NO: K192244(Traditional)
ATTN: Emerson Cano PHONE NO : 866 7868379
1860 Old Okeechobee Road, Suite 40SE DECISION MADE: 11-MAY-20
West Palm Beach FL 33409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Zirconia Blocks
De Corematrix Co.Ltd. 510(k) NO: K192262(Traditional)
ATTN: Kaixuan Liu PHONE NO : 86 183 79248893
No.40 NanBeigang Road, HuKou CountSE DECISION MADE: 29-MAY-20
JiuJiang CN 332599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gi-4000 Electrosurgical Generator
United States Endoscopy Group, Inc510(k) NO: K192265(Traditional)
ATTN: Carroll L. Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 21-MAY-20
Mentor OH 44060 510(k) STATEMENT
DEVICE: MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
Medron, LLC 510(k) NO: K192283(Traditional)
ATTN: David Kujawa PHONE NO : 801 9743010
1518 S Gladiola Street SE DECISION MADE: 06-MAY-20
Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM EP-6000 Video Processor
FUJIFILM Corporation 510(k) NO: K192286(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 01-MAY-20
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PDT-FACE
Bejing ADSS Development Co., Ltd. 510(k) NO: K192295(Traditional)
ATTN: Su CuiYing PHONE NO : 86 108362 5120
1-2, Jinyuan Road 36, Daxing EconoSE DECISION MADE: 01-MAY-20
Beijing CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K192342(Traditional)
ATTN: Chunqi Han PHONE NO : 86 571 87671223
Building 5, Building 6, No.597 KanSE DECISION MADE: 21-MAY-20
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiaPlus
Diadent Group International 510(k) NO: K192392(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43266 2315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 26-MAY-20
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity Angioplasty Balloon Catheter
Infinity Angioplasty Balloon Compa510(k) NO: K192399(Traditional)
ATTN: Tiffini Wittwer PHONE NO : 707 7996732
6865 N. Reynolds Rd Suite 200 SE DECISION MADE: 20-MAY-20
Toledo OH 43615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image Guidance System for Radiotherapy
Jiangsu Rayer Medical Technology C510(k) NO: K192405(Traditional)
ATTN: Peng Li PHONE NO : 86 510837 81608
Xishan Economic Development Zone SE DECISION MADE: 01-MAY-20
Wuxi CN 214192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phacoemulsification Needle (Tip) and Irrigation Sleeve
Raico LLC 510(k) NO: K192418(Traditional)
ATTN: Ravi Nallakrishnan PHONE NO : 630 988032
26 Plaza Dr SE DECISION MADE: 27-MAY-20
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crownjun Nylon Suture
Kono Seisakusho Co., Ltd. 510(k) NO: K192420(Traditional)
ATTN: Hiroyuki Arai PHONE NO : 03 3813 7414
3-43-16, Hongo SE DECISION MADE: 29-MAY-20
Bunkyo-ku JP 130-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Mainstream Module
Beijing Kingst Commercial & Trade 510(k) NO: K192446(Traditional)
ATTN: Judong Gao PHONE NO : 86 10 68158013
6th Floor of No.2-7,Road Beibinhe SE DECISION MADE: 21-MAY-20
Beijing CN 100053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Joline Kyphoplasty System Allevo
Joline GmbH & Co. KG 510(k) NO: K192449(Traditional)
ATTN: Peter Kohlbecher PHONE NO : 49 7471 98810
Neue RottenBurger Strasse 50 SE DECISION MADE: 27-MAY-20
Hechingen DE 72379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
Winner Medical Co., Ltd. 510(k) NO: K192463(Traditional)
ATTN: Dan Wang PHONE NO : 86 755 28138888
Winner Industrial Park, No. 660 BuSE DECISION MADE: 14-MAY-20
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Sidestream Module
Beijing Kingst Commercial & Trade 510(k) NO: K192488(Traditional)
ATTN: Judong Gao PHONE NO : 86 10 68158013
6th Floor of No.2-7,Road Beibinhe SE DECISION MADE: 22-MAY-20
Beijing CN 100053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kitazato ET Catheters
Kitazato Corporation 510(k) NO: K192540(Traditional)
ATTN: Futoshi Inoue PHONE NO : 81 35 8006055
Shibakoen Building, 1-1-8 ShibadaiSE DECISION MADE: 01-MAY-20
Tokyo JP 105-0012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Shandong Kangli Medical Equipment 510(k) NO: K192560(Traditional)
ATTN: Zhuang Liu PHONE NO : 86 0632 3466988
Huiquan East Road, Shizhong DistriSE DECISION MADE: 22-MAY-20
Zaozhuang CN 277117 510(k) STATEMENT
DEVICE: Actreen Hi-Lite Intermittent Urinary Catheters
B. Braun Medical Inc. 510(k) NO: K192577(Special)
ATTN: Anita J. Nemeth PHONE NO : 610 2660500
901 Marcon Boulevard SE DECISION MADE: 07-MAY-20
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON® Folate
Diasorin Inc. 510(k) NO: K192586(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Ave SE DECISION MADE: 06-MAY-20
Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUS831 Compressor Nebulizer
Globalcare Medical Technology Co.,510(k) NO: K192633(Traditional)
ATTN: Janice Deng PHONE NO : 86 760 22589901 608
7th Building, 39 Middle IndustrialSE DECISION MADE: 01-MAY-20
Xiaolan Town, Zhongshan City CN 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 308nm Excimer System
Chongqing Peninsula Medical Techno510(k) NO: K192642(Traditional)
ATTN: Zhang Sudi PHONE NO : 86 150125 78550
No.2-4, 2F Block I, Ke Yuan 4th RoSE DECISION MADE: 13-MAY-20
Chongqing CN 400041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZAGA Zygomatic System
Southern Implants (Pty) Ltd 510(k) NO: K192651(Traditional)
ATTN: Lauranda G Breytenbach PHONE NO : 27 12667 1046
1 Albert Road SE DECISION MADE: 07-MAY-20
Irene ZA 0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRV
Interacoustics A/S 510(k) NO: K192652(Traditional)
ATTN: Erik Nielsen PHONE NO : 45 63 713555
Audiometer Alle 1 SE DECISION MADE: 27-MAY-20
Middelfart DK 5500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimized Positioning System (OPS) Insight
Corin USA 510(k) NO: K192656(Traditional)
ATTN: Lucinda Gerber PHONE NO : 1 813 9774469
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 01-MAY-20
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainomix 360 e-CTA
Brainomix Limited 510(k) NO: K192692(Traditional)
ATTN: Gwilym Owen PHONE NO : 44 1865 582730
Suites 11-14 Suffolk House, 263 BaSE DECISION MADE: 28-MAY-20
Oxford GB ox2 7hn 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nuvo Nano Portable Oxygen Concentrator
Nidek Medical Products, Inc. 510(k) NO: K192693(Traditional)
ATTN: Olivia Mullen PHONE NO : 205 8567200
3949 Valley East Industrial Drive SE DECISION MADE: 07-MAY-20
Brimingham AL 35217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAL Single-Use Cannulas
MicroAire Surgical Instruments 510(k) NO: K192694(Traditional)
ATTN: Glenn Gerstenfeld PHONE NO : 434 9758344
3590 Grand Forks Blvd SE DECISION MADE: 14-MAY-20
Charlottesville VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
Kamiya Biomedical Company 510(k) NO: K192727(Traditional)
ATTN: Shawn Kaplan PHONE NO : 206 5758068 111
12779 Gateway Drive S SE DECISION MADE: 20-MAY-20
Tukwila WA 98168 510(k) STATEMENT
DEVICE: Chemfort CSTD
Simplivia Healthcare Ltd. 510(k) NO: K192866(Abbreviated)
ATTN: Itsik Shmueli PHONE NO : 972 4 6908830
North Industrial Zone SE DECISION MADE: 07-MAY-20
Kiryat Shmona IL 1101801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
Edan Instruments, Inc 510(k) NO: K192879(Traditional)
ATTN: Melody Huang PHONE NO : 86 755 26858736
#15 Jinhui Road, Jinsha Community SE DECISION MADE: 21-MAY-20
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revitive Medic Plus, Revitive Advanced 2
Actegy, Ltd. 510(k) NO: K192887(Traditional)
ATTN: Lawrence Brookfield PHONE NO : 44 01344 236037
Reflex, Cain Road SE DECISION MADE: 04-MAY-20
Bracknell GB RG12 1HL 510(k) STATEMENT
DEVICE: HealthVCF
Zebra Medical Vision Ltd. 510(k) NO: K192901(Traditional)
ATTN: Flair Bar PHONE NO : 972 9 8827795
Shefayim Commercial Center, PO BoxSE DECISION MADE: 12-MAY-20
Shefayim IL 6099000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stimuplex Onvision System
Philips Medical Systems Nederland 510(k) NO: K192914(Traditional)
ATTN: Gert de Vries PHONE NO : 31 6182 06281
Veenpluis 4-6 SE DECISION MADE: 27-MAY-20
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dymaxeon Spine System
Back 2 Basics Direct, LLC 510(k) NO: K192930(Traditional)
ATTN: Lou Keppler PHONE NO : 216 4475205
6701 Rockside Road, Suite 200 SE DECISION MADE: 12-MAY-20
Independence OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor
Shenzhen Mindray Bio-medical Elect510(k) NO: K192972(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 07-MAY-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
Penumbra, Inc 510(k) NO: K192981(Traditional)
ATTN: Teri Nguyen PHONE NO : 510 9952012
One Penumbra Place SE DECISION MADE: 28-MAY-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE Bone Transport System
NuVasive Specialized Orthopedics, 510(k) NO: K193016(Traditional)
ATTN: Madison Heffron PHONE NO : 949 5327868
101 Enterprise Suite 100 SE DECISION MADE: 08-MAY-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Critical Alert CommonPath Enterprise
Critical Alert 510(k) NO: K193043(Traditional)
ATTN: John Elms PHONE NO : 904 2606334
4901 Belfort Road, Suite 130 SE DECISION MADE: 11-MAY-20
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Purzir Dental Zirconia
3DBioCAD 510(k) NO: K193055(Traditional)
ATTN: Gyu D. Cho PHONE NO : 206 7865555
1525 N 4th St. SE DECISION MADE: 13-MAY-20
Renton WA 98057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonarMed AirWave Airway Monitoring System
SonarMed, Inc. 510(k) NO: K193058(Traditional)
ATTN: Laura Lyons PHONE NO : 317 4893161
12220 N. Meridian St., Ste. 150 SE DECISION MADE: 15-MAY-20
Carmel IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuraDERM Gel
3-D Matrix, Inc. 510(k) NO: K193085(Traditional)
ATTN: Lisa Spirio PHONE NO : 617 8756204
250 First Ave., Suite 205 SE DECISION MADE: 11-MAY-20
Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N. -Sistema de Implante Nacion510(k) NO: K193096(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 14-MAY-20
Sao Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biocore9 Humeral Resurfacing System
Biocore9, LLC. 510(k) NO: K193122(Traditional)
ATTN: Stan Matlak PHONE NO : 862 7036730
9 Whippany Road, Bldg A1, Unit 12 SE DECISION MADE: 15-MAY-20
Whippany NJ 07981 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 780
Shanghai United Imaging Healthcare510(k) NO: K193176(Traditional)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
No. 2258 Chengbei Rd, SE DECISION MADE: 05-MAY-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
BenQ Materials Corporation 510(k) NO: K193185(Traditional)
ATTN: Miranda Chang PHONE NO : 886 3 3748800
No, 29, Jianguo E. Rd., Gueishan SE DECISION MADE: 04-MAY-20
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RFID Localization System
Health Beacons, Inc. 510(k) NO: K193189(Traditional)
ATTN: Nancy Confrey PHONE NO : 978 2874635
34 Walden St. #753 SE DECISION MADE: 06-MAY-20
Concord MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIEW LCS
Coreline Soft Co., Ltd 510(k) NO: K193220(Traditional)
ATTN: Hyeyi Park PHONE NO :
4, 5F (Yeonnam-dong), 49, World CuSE DECISION MADE: 05-MAY-20
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hamilton-G5
Hamilton Medical AG 510(k) NO: K193228(Traditional)
ATTN: Simone Haller PHONE NO : 41 58 6102567
Via Crush 8 SE DECISION MADE: 04-MAY-20
Bonaduz CH 7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restoration® Modular Hip System
Howmedica Osteonics Corp. (aka Str510(k) NO: K193233(Special)
ATTN: Nora O'Connor PHONE NO : 353 21 4532529
325 Corporate Drive SE DECISION MADE: 27-MAY-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XV Lung Ventilation Analysis Software
4Dx Limited 510(k) NO: K193293(Traditional)
ATTN: Terrence Thiel PHONE NO : 61 2 99062984
Level 5 Suite 3, 468 St Kilda Rd SE DECISION MADE: 14-MAY-20
Melbourne AU 3004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pristina Serena Bright
GE Healthcare 510(k) NO: K193334(Traditional)
ATTN: Barthelemy Arman PHONE NO : 33 130704040
283 rue de la Miniere SE DECISION MADE: 15-MAY-20
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
Synedgen, Inc. 510(k) NO: K193336(Traditional)
ATTN: Shenda Baker PHONE NO : 909 4476858
1420 North Claremont Blvd. Suite 1SE DECISION MADE: 27-MAY-20
Claremont CA 91711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeneVision Central Monitoring System
Shenzhen Mindray Bio-medical Elect510(k) NO: K193391(Special)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 21-MAY-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UF(II) Bar holder abutment
DIO Corporation 510(k) NO: K193404(Traditional)
ATTN: JiAe Park PHONE NO : 82 51745 7836
66, Centumseo-ro, Haeundae-gu, SE DECISION MADE: 18-MAY-20
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XO Cross Support Catheter
Transit Scientific 510(k) NO: K193420(Traditional)
ATTN: Jenifer Arnold PHONE NO : 412 4963609
2757 South 300 West, Suite E SE DECISION MADE: 06-MAY-20
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Icotec AG 510(k) NO: K193423(Traditional)
ATTN: Marina Hess PHONE NO : 41 71757 0024
Industriestrasse 12 SE DECISION MADE: 22-MAY-20
9450 Altstaetten CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA Ambria
VITA Zahnfabrik GmbH H Rauter & Co510(k) NO: K193436(Traditional)
ATTN: Bernd Walker PHONE NO : 49 7761 562384
Spitelgasse 3 SE DECISION MADE: 14-MAY-20
Bad Sackingen DE D-79713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aqua Naina Sterile Saline Solution
Chemtex USA, Inc. 510(k) NO: K193441(Traditional)
ATTN: Haribabu Talasila PHONE NO : 973 4474373
27-29 Dwight Place SE DECISION MADE: 26-MAY-20
Fairfield NJ 07004-3303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDERE Lumbar Spacer System
Met One Technologies 510(k) NO: K193457(Traditional)
ATTN: Kyle Atwood PHONE NO : 915 3010834
513 W. San Antonio Ave, Suite C SE DECISION MADE: 12-MAY-20
El Paso TX 79901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The iNAP One Sleep Therapy System
Somnice, Inc. 510(k) NO: K193460(Traditional)
ATTN: Sujith Shetty PHONE NO : 886 3 5509623
5F, No. 22, Sec. 2, Shengyi Rd., HSE DECISION MADE: 26-MAY-20
Hsinchu County TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
Transit Scientific 510(k) NO: K193495(Traditional)
ATTN: Jenifer Arnold PHONE NO : 412 4963609
2757 South 300 West, Suite E SE DECISION MADE: 29-MAY-20
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CharmFil
Dentkist, Inc. 510(k) NO: K193496(Traditional)
ATTN: Shin Haeng Lee PHONE NO : 82 31 4583232
3, Nongshim-ro SE DECISION MADE: 06-MAY-20
Gunpo-si KR 15842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
Gynesonics, Inc 510(k) NO: K193516(Traditional)
ATTN: Diane King PHONE NO : 650 2163883
600 Chesapeake Drive SE DECISION MADE: 04-MAY-20
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZER, Portable X-ray System
Livermoretech Inc. 510(k) NO: K193535(Traditional)
ATTN: Jae Hong Kim PHONE NO : 1 214 2570113
801 North Jupiter Rd, Suite 200 SE DECISION MADE: 07-MAY-20
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLVE ENVI 600 Advanced Adipose System
LifeCell Corporation 510(k) NO: K193539(Traditional)
ATTN: Bozhana Hegarty PHONE NO : 908 9471100
One Millennium Way SE DECISION MADE: 28-MAY-20
Branchburg NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VarseoSmile Temp
BEGO Bremer Goldschlagerei Wilh. H510(k) NO: K193553(Traditional)
ATTN: Tanja Gotz PHONE NO : 49 421 2028394
Wilhelm-Herbst-Str. 1 SE DECISION MADE: 18-MAY-20
Bremen DE 28359 510(k) STATEMENT
DEVICE: LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
LV Liberty Vision Corporation 510(k) NO: K193602(Special)
ATTN: Paul T. Finger PHONE NO : 301 3198416
300 West Road, Unit 2 SE DECISION MADE: 29-MAY-20
Portsmouth NH 03874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precice® Screws
NuVasive Specialized Orthopedics, 510(k) NO: K193617(Traditional)
ATTN: Madison Heffron PHONE NO : 949 5327868
101 Enterprise, Suite 100 SE DECISION MADE: 08-MAY-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Frozen N
Yozma BmTech Co., Ltd. 510(k) NO: K193665(Traditional)
ATTN: Jenny Cho PHONE NO : 82 31 7395544
#609, 808, 1001~1007, Jungang InduSE DECISION MADE: 28-MAY-20
Seongnam-si KR 13202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
4Web, Inc. 510(k) NO: K200002(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 29-MAY-20
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable ECG Cable
Shenzhen Changke Connect Electroni510(k) NO: K200026(Traditional)
ATTN: Yahui Zhou PHONE NO : 86 1361 3012560
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 12-MAY-20
Longgang District, Shenzhen CN 51510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReWalk P6.0
ReWalk Robotics Ltd. 510(k) NO: K200032(Traditional)
ATTN: Ofir Koren PHONE NO : 972 54 5225792
3 Hetnufa st., POB Box- 161 SE DECISION MADE: 26-MAY-20
Yokneam IL 2069203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultravision Visual Field Clearing System
Alesi Surgical Ltd. 510(k) NO: K200035(Traditional)
ATTN: David Broderick PHONE NO : 44 0 2920291022
Cardiff Medicentre, Heath Park SE DECISION MADE: 04-MAY-20
Cardiff GB CF14 4UJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalys Precision Laser System
AMO Manufacturng USA, LLC 510(k) NO: K200056(Traditional)
ATTN: Laarni Ricafort PHONE NO : 408 2734016
510 Cottonwood Drive SE DECISION MADE: 18-MAY-20
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoSecond Nd: YAG Laser System
Shanghai Apolo Medical Technology 510(k) NO: K200116(Traditional)
ATTN: Felix Li PHONE NO : 86 138 49190618
4F, Building A, No.388, Yindu RoadSE DECISION MADE: 28-MAY-20
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LiteSaber Wire Torque Assist Device
Vesatek, LLC 510(k) NO: K200120(Traditional)
ATTN: David Look PHONE NO : 949 7529642
17171 Daimler Street SE DECISION MADE: 07-MAY-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InCore MPJ System
Nextremity Solutions, Inc. 510(k) NO: K200124(Traditional)
ATTN: Elise Fox PHONE NO : 574 3762062
210 North Buffalo Street SE DECISION MADE: 13-MAY-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY Assert Self-Contained Biological Indicator
STERIS Corporation 510(k) NO: K200126(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Road SE DECISION MADE: 22-MAY-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
Covidien, llc 510(k) NO: K200146(Traditional)
ATTN: Shani Frenkel PHONE NO : 408 3287310
15 Hampshire Street SE DECISION MADE: 07-MAY-20
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VFS1 Bipolar Electrosurgical Generator
FHC, Inc. 510(k) NO: K200169(Traditional)
ATTN: Kelly Moeykens PHONE NO : 207 6665651 2195
1201 Main Street SE DECISION MADE: 14-MAY-20
Bowdoin ME 04287 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stone Retrieval Balloon
Hangzhou AGS MedTech Co., Ltd. 510(k) NO: K200173(Traditional)
ATTN: Chunqi Han PHONE NO : 86 571 87671223
Building 5, Building 6, No.597 KanSE DECISION MADE: 01-MAY-20
Hangzhou CN 311106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
Stryker Sustainability Solutions 510(k) NO: K200205(Traditional)
ATTN: Mia McCorkel PHONE NO : 480 7635333
1810 W Drake Drive SE DECISION MADE: 13-MAY-20
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph mMR with syngo MR E11P-AP01 system software
Siemens Medical Solutions, USA, In510(k) NO: K200213(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 11-MAY-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONG-TL VBR System, KONG-C VBR System
icotec ag 510(k) NO: K200235(Traditional)
ATTN: Marina Hess PHONE NO : 41 71 7570024
Industriestrasse 12 SE DECISION MADE: 29-MAY-20
Altstaetten CH 9450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JPS JuniOrtho Plating System
Orthofix Srl 510(k) NO: K200246(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 39 04567 19000
Via delle Nazioni, 9 SE DECISION MADE: 22-MAY-20
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Getinge Assured MI Steam Migrating Integrator
SteriTec Products MFG Co Inc 510(k) NO: K200252(Traditional)
ATTN: Jonathan Rutigliano PHONE NO : 303 6604201
74 Inverness Drive East SE DECISION MADE: 21-MAY-20
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
Ethicon Endo-Surgery 510(k) NO: K200253(Traditional)
ATTN: Emily Nesbitt PHONE NO : 787 2726500
475 Cale C SE DECISION MADE: 27-MAY-20
Guaynabo PR 00696 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Headless Compression Screw System
OsteoCentric Extremities, LLC 510(k) NO: K200259(Special)
ATTN: Todd Evans PHONE NO : 1 800 9690639
5113 Southwest Parkway, Suite 150 SE DECISION MADE: 04-MAY-20
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CariCloud
Caristo Diagnostics 510(k) NO: K200274(Traditional)
ATTN: James Davis PHONE NO : 44 0 1865950720
New Barclay House, 234 Botley RoadSE DECISION MADE: 21-MAY-20
Oxford GB OX20HP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
Phadia AB 510(k) NO: K200279(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 181 65000
Rapsgatan 7P SE DECISION MADE: 01-MAY-20
Uppsala SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BP-BT Kiosk
LD Technology LLC 510(k) NO: K200287(Traditional)
ATTN: Albert Maarek PHONE NO : 305 3799900
100 N. Biscayne Blvd Suite 502 SE DECISION MADE: 15-MAY-20
Miami FL 33132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
SeaSpine Orthopedics Corporation 510(k) NO: K200290(Traditional)
ATTN: Caryn Sailor PHONE NO : 949 8557174
2 Goodyear SE DECISION MADE: 11-MAY-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode System with vTone Applicator
InMode Ltd. 510(k) NO: K200293(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 05-MAY-20
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reform Pedicle Screw System
Precision Spine 510(k) NO: K200303(Traditional)
ATTN: Micheal C. Dawson PHONE NO : 973 4557150 128___
2050 Executive Drive SE DECISION MADE: 19-MAY-20
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPseal
Guard Medical Inc. 510(k) NO: K200305(Traditional)
ATTN: Machiel Van der Leest PHONE NO : 888 4173644
10 East 40th Street, Suite 3310 SE DECISION MADE: 26-MAY-20
New York NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziostation2
Ziosoft, Inc. 510(k) NO: K200315(Traditional)
ATTN: Tsuyoshi Nagata PHONE NO : 81 3 54271903
MitaKokusai Bldg., 1-4-28 Mita SE DECISION MADE: 05-MAY-20
Minato-ku JP 108-0073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Support Catheter
QXMedical, LLC 510(k) NO: K200317(Traditional)
ATTN: Fernando Di Caprio PHONE NO : 651 8422053
2820 Patton Road SE DECISION MADE: 14-MAY-20
Roseville MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Neocis Inc. 510(k) NO: K200348(Traditional)
ATTN: Thomas E. Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 08-MAY-20
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axis Spine Technologies ALIF
Axis Spine Technologies Ltd 510(k) NO: K200352(Traditional)
ATTN: Edwin Lindsay PHONE NO : 44 791 7134922
Suite 204, 54-56 Victoria Street, SE DECISION MADE: 20-MAY-20
St. Albans GB AL1 3HZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Distal Humerus Plating System
Skeletal Dynamics, Inc. 510(k) NO: K200367(Traditional)
ATTN: Ana M. Escagedo PHONE NO : 305 5967585
7300 N. Kendall Drive, Suite 400 SE DECISION MADE: 14-MAY-20
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. DERMATAC Drape
KCI USA, Inc 510(k) NO: K200390(Traditional)
ATTN: Margaret Marsh PHONE NO : 210 2556481
6203 Farinon Drive SE DECISION MADE: 18-MAY-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA II Knee System (EXULT Knee Replacement System)
Corentec Co., Ltd 510(k) NO: K200395(Special)
ATTN: Sungwon Yang PHONE NO : 82 41 5857144
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 07-MAY-20
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Systane iLux2
Tear Film Innovations, Inc. 510(k) NO: K200400(Traditional)
ATTN: Neal Hartman PHONE NO : 706 4449555
5924 Balfour Court, Suite 100 SE DECISION MADE: 21-MAY-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reconnaissance PV .018 OTW Digital IVUS Catheter
Philips Image Guided Therapy Corpo510(k) NO: K200410(Traditional)
ATTN: Mary Stanners PHONE NO : 1 858 7641296
3721 Valley Centre Drive Ste 500 SE DECISION MADE: 22-MAY-20
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIST Radial Access Catheter
RIST Neurovascular, Inc. 510(k) NO: K200417(Traditional)
ATTN: Marianne Grumwaldt PHONE NO : 305 4953883
11611 Interchange Circle South SE DECISION MADE: 02-MAY-20
Miramar FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kalera Vacuum Aspiration Catheter (K-VAC)
Kalera Medical, Inc. 510(k) NO: K200419(Traditional)
ATTN: Jee Shin PHONE NO : 760 8610818
13240 Evening Creek Drive S., SuitSE DECISION MADE: 22-MAY-20
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D GraftRasp System
SurGenTec 510(k) NO: K200431(Traditional)
ATTN: Andrew Shoup PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 18-MAY-20
Boca Raton FL 33847 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst+, Catalyst+ HD
C-Rad Positioning AB 510(k) NO: K200435(Traditional)
ATTN: Thomas Matzen PHONE NO : 46 18 666930
Bredgränd 18 SE DECISION MADE: 07-MAY-20
Uppsala SE 75320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
YTY Industry (Manjung) Sdn Bhd 510(k) NO: K200453(Traditional)
ATTN: Punitha Samy PHONE NO : 605 6908533
Lot 1422-1424, Batu 10 Lekir SE DECISION MADE: 01-MAY-20
Sitiawan MY 32020 510(k) STATEMENT
DEVICE: Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
CC Wellness LLC 510(k) NO: K200457(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 22-MAY-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V30 system, V20 system, V10 system, V-FC Handpiece
Viora Ltd. 510(k) NO: K200468(Traditional)
ATTN: Simona Forman Krant PHONE NO : 972 9 9551344
6 Hagavish Street SE DECISION MADE: 21-MAY-20
Netanya IL 4250706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AquaPulse Auxiliary Water Connector
GA Health Company Limited 510(k) NO: K200479(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 852 2833 9010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 15-MAY-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
Boston Scientific Corporation 510(k) NO: K200483(Traditional)
ATTN: Inderdeep Tiwana PHONE NO :
100 Boston Scientific Way SE DECISION MADE: 21-MAY-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instrument-Electrodes
LivsMed Inc. 510(k) NO: K200501(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 70 77094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 11-MAY-20
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Vitamin D Total (VitD)
Siemens Healthcare Diagnostics Inc510(k) NO: K200509(Traditional)
ATTN: Paul DaSilva PHONE NO : 914 5243141
511 Benedict Avenue SE DECISION MADE: 29-MAY-20
Tarrytown NY 102591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA ONE Brain application
Medtech S.A. 510(k) NO: K200511(Traditional)
ATTN: Serge Tabet PHONE NO : 33 4671 07740
ZAC Eureka - 900 Rue du Mas de VerSE DECISION MADE: 29-MAY-20
Montpellier FR 34000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
bioMérieux S.A. 510(k) NO: K200512(Traditional)
ATTN: Alexia Bosquet PHONE NO : 33 047 8875020
376 Chemin de l'Orme SE DECISION MADE: 07-MAY-20
Marcy L'Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Diode Laser Hair Removal System
Weifang Mingliang Electronics CO.,510(k) NO: K200525(Traditional)
ATTN: Li MingLiang PHONE NO : 86 15854 424546
No.13426, Yuqing Street, High-TechSE DECISION MADE: 27-MAY-20
Weifang CN 261000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZeeroMED View
O3 Enterprise SRL 510(k) NO: K200546(Traditional)
ATTN: Andrea Poli PHONE NO : 39 333 4082400
Padriciano 99 SE DECISION MADE: 05-MAY-20
Tieste IT 34149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
SPINEART 510(k) NO: K200571(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 Chemin du Pre Fleuri SE DECISION MADE: 01-MAY-20
PLAN LES OUATES CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O-Genesis Graft Delivery System
Orthofix, Inc. 510(k) NO: K200606(Traditional)
ATTN: Troy Brooks PHONE NO : 214 9372047
3451 Plano Parkway SE DECISION MADE: 01-MAY-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspire Mechanical Aspirator G
Control Medical Technology 510(k) NO: K200629(Special)
ATTN: Shawn Fojtik PHONE NO : 801 8918610
2757 South 300 West Suite F (ZIEN)SE DECISION MADE: 29-MAY-20
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTAPORE SHAPE
Baxter Healthcare Corporation 510(k) NO: K200640(Traditional)
ATTN: Phillip Romei PHONE NO : 224 9482652
25212 W. Illinois Route 120 SE DECISION MADE: 08-MAY-20
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMF Revision TT Cones
LimaCorporate S.p.A 510(k) NO: K200653(Traditional)
ATTN: Roberto Gabetta PHONE NO : 39 0432 945511
Via Nazionale 52 SE DECISION MADE: 07-MAY-20
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermalux Tri-Wave MD
Aesthetic Technology Ltd. 510(k) NO: K200659(Traditional)
ATTN: Dale Needham PHONE NO : 44 0845 6891789
211 Europa Blvd. SE DECISION MADE: 09-MAY-20
Warrington GB WA5 7TN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Guide® Surgical Navigation System
X-Nav Technologies,LLC. 510(k) NO: K200662(Special)
ATTN: Fred Cowdery PHONE NO : 267 4360414
1555 Bustard Road, Suite 75 SE DECISION MADE: 21-MAY-20
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K200699(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 07-MAY-20
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
Creagh Medical Ltd. 510(k) NO: K200700(Traditional)
ATTN: Amy Yanta PHONE NO : 353 90 9646306
IDA Business Park SE DECISION MADE: 14-MAY-20
Ballinasloe IE H53 HY09 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Skeletal Dynamics Midshaft Humerus Plating System
Skeletal Dynamics, Inc. 510(k) NO: K200701(Traditional)
ATTN: Diana Taylor PHONE NO : 305 5967585
7300 N. Kendall Drive, Suite 400 SE DECISION MADE: 14-MAY-20
Miami FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC. (now a p510(k) NO: K200737(Traditional)
ATTN: Agatha Szeliga PHONE NO : 604 4227516
8329 Eastlake Drive, Unit 101 SE DECISION MADE: 21-MAY-20
Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Treatment Systems
Shanghai Apolo Medical Technology 510(k) NO: K200746(Traditional)
ATTN: Felix Li PHONE NO : 86 138491 90618
4F, Building A, No.388, Yindu RoadSE DECISION MADE: 15-MAY-20
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuriLens Plus Preservative Free Saline
The LifeStyle Company, Inc. 510(k) NO: K200747(Traditional)
ATTN: Tom Seidner PHONE NO : 800 6220777
6 Paragon Way Suite 112 SE DECISION MADE: 15-MAY-20
Freehold NJ 07728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUBEScan BioCon-900S
Mcube Technology Co., Ltd. 510(k) NO: K200749(Traditional)
ATTN: Hye-Ri Choi PHONE NO : 82 02 34217780
#803, 123, Bonghwasan-ro, JungnangSE DECISION MADE: 19-MAY-20
Seoul KP 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Photodynamic Therapy (PDT) Equipment
Shangdong Huamei Technology Co., L510(k) NO: K200751(Traditional)
ATTN: Xu QingHua PHONE NO : 86 536211 0001
No. 588, Changning Street, High-teSE DECISION MADE: 21-MAY-20
Weifang CN 261205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
Howmedica Osteonics Corp. 510(k) NO: K200782(Traditional)
ATTN: Nora O'Connor PHONE NO : 353 21 4532529
325 Corporate Drive SE DECISION MADE: 13-MAY-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
Ethicon Endo-Surgery, Llc 510(k) NO: K200841(Traditional)
ATTN: Nathan Anderson PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 11-MAY-20
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Balteum™ Lumbar Plate System
Huvexel Co., Ltd 510(k) NO: K200846(Traditional)
ATTN: Sung Kyu Hur PHONE NO : 82 31 7763690
101-105 Megacenter, SKn TechnoparkSE DECISION MADE: 05-MAY-20
Seongnam-si KR 13207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
M.I. Tech Co., Ltd 510(k) NO: K200860(Traditional)
ATTN: Inae Kim PHONE NO : 82 70 40347450
174, Habuk 2-gil, Jinwi-myeon SE DECISION MADE: 20-MAY-20
Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
Shenzhen Beacon Display Technology510(k) NO: K200864(Traditional)
ATTN: Fu Ailing PHONE NO : 86 0755 36868363 5150
12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 19-MAY-20
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
Hologic, Inc. 510(k) NO: K200866(Special)
ATTN: Anila Tarte PHONE NO : 858 4108055
10210 Genetic Center Drive SE DECISION MADE: 17-MAY-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc 510(k) NO: K200870(Special)
ATTN: Jocelyn Kersten PHONE NO : 425 7615912
316 Occidental Avenue South, SuiteSE DECISION MADE: 01-MAY-20
Seattle WA 98104 510(k) STATEMENT
DEVICE: Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Control Medical Technology 510(k) NO: K200871(Special)
ATTN: Shawn Fojtik PHONE NO : 801 8918610
2757 South 300 West Suite F (ZIEN)SE DECISION MADE: 04-MAY-20
Salt Lake City UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natus NeuroWorks
Natus Medical Incorporated DBA Exc510(k) NO: K200878(Traditional)
ATTN: Sanjay Mehta PHONE NO : 608 8298673
2568 Bristol Circle SE DECISION MADE: 18-MAY-20
Oakville CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meridian Anterior Plate System, Regatta Lateral Plate System
SeaSpine Orthopedics Corporation 510(k) NO: K200885(Traditional)
ATTN: Aly Alvarez PHONE NO : 760 2165622
5770 Armada Drive SE DECISION MADE: 28-MAY-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSS Balloon Guide Catheter
Marblehead Medical 510(k) NO: K200910(Third Party - Traditional)
ATTN: Kristin Mortenson PHONE NO : 612 2021142
11600 96th Ave N SE DECISION MADE: 02-MAY-20
Maple Grove MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Healix Compression Screw System
Nvision Biomedical Technologies, I510(k) NO: K200914(Special)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 05-MAY-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Azurion R2.1
Philips Medical Systems Nederland 510(k) NO: K200917(Special)
ATTN: Michelle Campbell PHONE NO : 31 618 345796
Veenpluis 4-6 SE DECISION MADE: 01-MAY-20
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Idys ALIF ZP 3DTi
Clariance, SAS 510(k) NO: K200920(Special)
ATTN: Fadwa Bahr PHONE NO : 33 03 21161215
18 rue Robespierre SE DECISION MADE: 29-MAY-20
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntec Non-Sterile Steinmann Pins System
Syntec Scientific Corporation 510(k) NO: K200933(Special)
ATTN: Nicole Tseng PHONE NO : 886 4798 7099
No.2, Kung San Road Chuan Shing InSE DECISION MADE: 05-MAY-20
Chang Hua TW 50971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mazor X
Mazor Robotics Ltd. 510(k) NO: K200935(Special)
ATTN: Shiran Conforti PHONE NO : 972 4 6187100
5 Shacham St. North Industrial ParSE DECISION MADE: 08-MAY-20
Caesarea IL 3079567 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invictus™ CT Spinal Fixation System
Alphatec Spine, Inc. 510(k) NO: K200936(Traditional)
ATTN: Ruby Zheng PHONE NO : 760 4946884
5818 El Camino Real SE DECISION MADE: 22-MAY-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIEXPERT 2 PLUS
Adani 510(k) NO: K200944(Traditional)
ATTN: Vladimir Linev PHONE NO : 375 17 3490000
7 Selitsky str. SE DECISION MADE: 26-MAY-20
Minsk BY 220075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventricular Catheter
Aesculap, Inc. 510(k) NO: K200950(Special)
ATTN: Kathy A. Racosky PHONE NO : 610 9849291
3773 Corporate Parkway SE DECISION MADE: 08-MAY-20
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Thoracolumbar Plates
NuVasive, Incorporated 510(k) NO: K200956(Traditional)
ATTN: Daniela Mahan PHONE NO : 858 4582285
7475 Lusk Blvd. SE DECISION MADE: 21-MAY-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc. 510(k) NO: K200961(Special)
ATTN: Rachel Osbeck PHONE NO : 904 3735940
203 Fort Wade Rd., Suite 150 SE DECISION MADE: 08-MAY-20
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonosite PX Ultrasound System
FUJIFILM SonoSite, Inc. 510(k) NO: K200964(Third Party - Traditional)
ATTN: Sudipta Chakrabarti PHONE NO : 425 9511371
21919 30th Drive SE SE DECISION MADE: 08-MAY-20
Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Icare HOME Tonometer
Icare Finland Oy 510(k) NO: K200966(Special)
ATTN: Hannes Hyvonen PHONE NO : 358 9 87751150
Ayritie 22 SE DECISION MADE: 07-MAY-20
Vantaa FI 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXT MATRIXX System
Nexxt Spine LLC 510(k) NO: K200969(Special)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 21-MAY-20
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K200979(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 28-MAY-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardian Needle Electrode
Rhythmlink International, LLC 510(k) NO: K200984(Special)
ATTN: Gabriel Orsinger PHONE NO : 803 3659664
1140 First Street South SE DECISION MADE: 27-MAY-20
Columbia SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maximus System
Hill-Rom Services Pte Ltd 510(k) NO: K200988(Special)
ATTN: Alvin Tan PHONE NO : 65 6499 7391
1 Yishun Ave 7 SE DECISION MADE: 26-MAY-20
Singapore SG 768923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance Endoscope Processing System
STERIS Corporation 510(k) NO: K200989(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 14-MAY-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOL Spinal Interbody System
Cutting Edge Spine, LLC 510(k) NO: K200991(Special)
ATTN: Kyle Kuntz PHONE NO : 704 2430892
101 Waxhaw Professional Park, SuitSE DECISION MADE: 13-MAY-20
Waxhaw NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insignia™ Anterior Cervical Plate System
Alphatec Spine, Inc. 510(k) NO: K200995(Traditional)
ATTN: Sandy Gill PHONE NO : 760 4733858
5818 El Camino Real SE DECISION MADE: 21-MAY-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumipulse G CA19-9-N
Fujirebio Diagnostics, Inc. 510(k) NO: K200997(Special)
ATTN: Kristin Maddaloni PHONE NO : 484 3952126
201 Great Valley Parkway SE DECISION MADE: 14-MAY-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
iRay Technology Taicang Ltd. 510(k) NO: K201004(Special)
ATTN: Meng Li PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 01-MAY-20
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc. 510(k) NO: K201011(Special)
ATTN: Alexandra Theisen PHONE NO : 763 5266758
8200 Coral Sea Street N.E. SE DECISION MADE: 13-MAY-20
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc. 510(k) NO: K201012(Special)
ATTN: Deep Pal PHONE NO : 425 2193412
22100 Bothell Everett Highway SE DECISION MADE: 01-MAY-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syngo.CT CaScoring
Siemens Medical Solutions USA, Inc510(k) NO: K201034(Special)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 14-MAY-20
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
iRay Technology Taicang Ltd. 510(k) NO: K201043(Special)
ATTN: Junjie Qian PHONE NO : 86 051253 690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 12-MAY-20
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PercuNav Image Fusion and Interventional Navigation
Philips Ultrasound, Inc 510(k) NO: K201053(Third Party - Traditional)
ATTN: Travis Catania PHONE NO : 908 2279423
22100 Bothell Everett Highway SE DECISION MADE: 14-MAY-20
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Accuvue+
Radmedix LLC 510(k) NO: K201058(Special)
ATTN: Gabriel Issa PHONE NO : 844 7236334
2510 Lance Dr. SE DECISION MADE: 06-MAY-20
Dayton OH 45409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo Ultrasound Apps Suite (sUSAS)
Siemens Medical Solutions, USA, In510(k) NO: K201062(Special)
ATTN: Christine Dunbar PHONE NO : 925 3742045
685 East Middlefield Road SE DECISION MADE: 18-MAY-20
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
Medtronic, Inc. 510(k) NO: K201068(Special)
ATTN: Sammie C. Joseph-Fredericks PHONE NO : 763 5262337
7611 Northland Drive SE DECISION MADE: 21-MAY-20
Minneapolis MN 55428 510(k) STATEMENT
DEVICE: NuVasive® ACP System
NuVasive, Incorporated 510(k) NO: K201078(Special)
ATTN: Ivanna Lopez PHONE NO : 858 9091878
7475 Lusk Blvd. SE DECISION MADE: 20-MAY-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advincula Delineator Uterine Manipulator
CooperSurgical, Inc. 510(k) NO: K201086(Special)
ATTN: Kyle Hooper PHONE NO : 203 6013230 3370
95 Corporate Drive SE DECISION MADE: 21-MAY-20
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntraMarX 3D Radiopaque Marker
AnX Robotica Corp. 510(k) NO: K201106(Special)
ATTN: Steven Gu PHONE NO : 510 4492956
1047 Serpentine Ln. Suite 100, PleSE DECISION MADE: 21-MAY-20
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GentleMax Pro Plus
Candela Corporation 510(k) NO: K201111(Special)
ATTN: Yverre Bobay PHONE NO : 617 6696181
251 Locke Dr SE DECISION MADE: 26-MAY-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
Arrow International Inc. 510(k) NO: K201112(Special)
ATTN: Shajunath Nirupama PHONE NO : 978 2505100 725187
16 Elizabeth Drive SE DECISION MADE: 27-MAY-20
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
Medtronic, Inc. 510(k) NO: K201118(Special)
ATTN: Jen Correa PHONE NO : 949 2975494
5290 California Ave SE DECISION MADE: 26-MAY-20
Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Safecare Biotech(Hangzhou)Co.,Ltd.510(k) NO: K201120(Traditional)
ATTN: Alex Qiu PHONE NO : 86 571 89712897
Building 2/203 No.18 Haishu Rd.,CaSE DECISION MADE: 27-MAY-20
Hangzhou CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPAZ Mobile DR System
DRGEM Corporation 510(k) NO: K201124(Special)
ATTN: Ki-Nam Yang PHONE NO : 82 2 8698566
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 19-MAY-20
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Juniper Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K201130(Third Party - Traditional)
ATTN: Hyunjung Lee PHONE NO : 425 2815061
685 East Middlefield Road SE DECISION MADE: 26-MAY-20
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: firefly T-2
Firstkind Limited 510(k) NO: K201131(Special)
ATTN: Neil Buckley PHONE NO : 44 0 1494572040
Hawk House, Peregrine Business ParSE DECISION MADE: 28-MAY-20
High Wycombe GB HP13 7DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cure™ Lumbar Plate System
Meditech Spine, LLC 510(k) NO: K201136(Special)
ATTN: Bruce Dunaway PHONE NO : 678 9745287
1447 Peachtree St NE Suite 440 SE DECISION MADE: 12-MAY-20
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CFP-3131, CFP-2222
MX Imaging, Inc. 510(k) NO: K201172(Traditional)
ATTN: John Ross PHONE NO : 310 3813800
2894 Columbia Street SE DECISION MADE: 29-MAY-20
Torrance CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLab Polaris Multi-Modality Guidance System
Boston Scientific 510(k) NO: K201178(Special)
ATTN: Kevin Lam PHONE NO : 763 2576482
Three Scimed Place SE DECISION MADE: 29-MAY-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lascod Impression Materials
Lascod Spa 510(k) NO: K201184(Third Party - Traditional)
ATTN: Gualtiero Cozzi PHONE NO : 39 055 421578
Via Longo, 18 SE DECISION MADE: 05-MAY-20
Sesto Fiorentino IT 50019 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Stealthstation S8 Spine Software v1.3.0
Medtronic Navigation, Inc. 510(k) NO: K201189(Special)
ATTN: Jason Woehrle PHONE NO : 720 8903300
826 Coal Creek Circle SE DECISION MADE: 29-MAY-20
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 212
TOTAL WITH SUMMARIES 202
TOTAL WITH STATEMENTS 10
