510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2019
DEVICE: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
Embla Systems 510(k) NO: K180001(Abbreviated)
ATTN: Sanjay Mehta PHONE NO : 905 2875055
1 Hines Road Suite 202 SE DECISION MADE: 27-SEP-19
Kanata CA K2K 3C7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTAI Surgery Navigation System
Intai Technology Corporation 510(k) NO: K180523(Traditional)
ATTN: Shih-Chang Chuang PHONE NO : 886 4 23595336 23489
No. 9 Jingke Rd., Nantun Dist., SE DECISION MADE: 20-SEP-19
Taichung City TW 40852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire Dorsal Comfort Fit
Crane Dental Laboratory, Inc 510(k) NO: K181416(Traditional)
ATTN: Sharlene Schultz PHONE NO : 585 7305100
3515 Buffalo Road Suite 30 SE DECISION MADE: 17-SEP-19
Rochester NY 14624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clyra Wound Irrigation Solution
Clyra Medical Technologies Inc. 510(k) NO: K181428(Traditional)
ATTN: Steven V. Harrison PHONE NO : 949 6439540
14921 Chestnut St. SE DECISION MADE: 20-SEP-19
Westminster CA 92683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Roosin Xeroform Petrolatum Dressing
Roosin Medical Co., Ltd 510(k) NO: K181478(Traditional)
ATTN: Charles Shen PHONE NO : 086 523 86908085
8 Yuandong Road, KouAn Town, GaogaSE DECISION MADE: 13-SEP-19
Taizhou CN 225321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precise SHP Diode Laser
CAO Group, Inc. 510(k) NO: K181601(Traditional)
ATTN: Robert K. Larsen PHONE NO : 801 2569282
4628 West Skyhawk Drive SE DECISION MADE: 09-SEP-19
West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pioneer Elite Diode Laser
CAO Group, Inc. 510(k) NO: K181602(Traditional)
ATTN: Robert K. Larsen PHONE NO : 801 2569282
4628 West Skyhawk Drive SE DECISION MADE: 10-SEP-19
West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision Spine Navigation Instrumentation
Precision Spine, Inc. 510(k) NO: K181606(Traditional)
ATTN: Michael C. Dawson PHONE NO : 601 4204244
2050 Executive Drive SE DECISION MADE: 27-SEP-19
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterling Supreme Diode Laser
CAO Group, Inc. 510(k) NO: K181614(Traditional)
ATTN: Robert K. Larsen PHONE NO : 801 2569282
4628 West Skyhawk Drive SE DECISION MADE: 10-SEP-19
West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klinly Ultrasonic Tongue Cleaner
KEA Products Ltd 510(k) NO: K181986(Traditional)
ATTN: Michael Schmidt PHONE NO : 852 2798 6882
10C, Meyer Ind. Bldg, 2 Chong Yip SE DECISION MADE: 06-SEP-19
Kwun Tong HK 00000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dia-Proseal
Diadent Group International 510(k) NO: K182009(Traditional)
ATTN: Myung Sub Kim PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 26-SEP-19
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPnRIDE
UPnRIDE Robotics Ltd. 510(k) NO: K182257(Traditional)
ATTN: Yoram Levy PHONE NO : 972 4 6110061
Kochav Yokneam Bld. SE DECISION MADE: 12-SEP-19
Yokneam IL 2069204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTRAN APM-Plus
VORTRAN Medical Technology 1, Inc.510(k) NO: K182292(Traditional)
ATTN: James Lee PHONE NO : 916 6488460
21 Goldenland Court, Suite 100 SE DECISION MADE: 18-SEP-19
Sacramento CA 95834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Secret RF Smartcure Applicator with electrodes
Ilooda Co., Ltd. 510(k) NO: K182355(Traditional)
ATTN: Yun-Jung Ha PHONE NO : 82 031 2101622
120, Jangan-ro 458 Beon-gil, JangaSE DECISION MADE: 06-SEP-19
Suwon-Si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "SupaScoota" Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
Eurogreen International Inc. 510(k) NO: K182631(Traditional)
ATTN: David Hsieh PHONE NO : 886 4 8319633
No. 48, Lane 220, Sec. 1, Fu-Zun RSE DECISION MADE: 19-SEP-19
Chang-Hua County CN 51055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medi-Direct TENS Pen
JKH USA, LLC 510(k) NO: K182671(Traditional)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
1142 S. Diamond Bar Blvd, #861 SE DECISION MADE: 21-SEP-19
Diamond Bar CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLR8 Abdominal Wound Dressing Kit
Genadyne Biotechnologies 510(k) NO: K182722(Traditional)
ATTN: Swara Vashi PHONE NO : 516 4878787
16 Midland Ave SE DECISION MADE: 27-SEP-19
Hicksville NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable Temperature Probe
Shenzhen Caremed Medical Technolog510(k) NO: K182751(Traditional)
ATTN: Alan Xie PHONE NO : 86 755 36560977 889
East Side, 3/F, C Building, KeluntSE DECISION MADE: 06-SEP-19
Dalang Office, Longhua District, S510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
TOP Corporation 510(k) NO: K182765(Traditional)
ATTN: Sho Yokoya PHONE NO :
19-10 Senju Nakai-cho SE DECISION MADE: 03-SEP-19
Adachi-ku JP 120-0035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
Beckman Coulter 510(k) NO: K182886(Traditional)
ATTN: Samy Puccio PHONE NO : 305 3804509
11800 SW 147th Ave SE DECISION MADE: 06-SEP-19
Miami FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinix Universal Composite
Nobio Ltd. 510(k) NO: K182921(Traditional)
ATTN: Inbal Beinglass Peled PHONE NO : 972 3 9059966
8 Hamatechet St. SE DECISION MADE: 13-SEP-19
Kadima IL 6092000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steerable catheter control system
Stereotaxis, Inc. 510(k) NO: K183027(Traditional)
ATTN: Kenneth H. Lock PHONE NO : 314 6786123
4320 Forest Park Avenue, Suite 100SE DECISION MADE: 06-SEP-19
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS Belt (Model MC0485)
Dongguan Yingfeng Metal & Plastic 510(k) NO: K183103(Traditional)
ATTN: Zesheng Chen PHONE NO : 86 769 83349883
Bianpu District, Lianhu Road, QiaoSE DECISION MADE: 18-SEP-19
Dongguan CN 523520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuStat
Beeken Biomedical, LLC 510(k) NO: K183190(Traditional)
ATTN: Richard A. Kendall PHONE NO : 888 4977376
378 Page St, Suite 201 SE DECISION MADE: 25-SEP-19
Stoughton MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus TENS Therapy, Model PM710-M/-L
Omron Healthcare, Inc. 510(k) NO: K183215(Traditional)
ATTN: Renee Thornborough PHONE NO : 847 2475626
1925 West Field Court, Suite 100 SE DECISION MADE: 07-SEP-19
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc510(k) NO: K183268(Traditional)
ATTN: Kimberly Rendon PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 10-SEP-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K3
Osstem Implant Co., Ltd. 510(k) NO: K183347(Traditional)
ATTN: Hyeri Han PHONE NO : 82 070 46260881
1st Floor, B-dong, 135 Gasan DigitSE DECISION MADE: 04-SEP-19
Seoul KR 08504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bellavista
Imtmedical AG 510(k) NO: K183364(Traditional)
ATTN: Beat Keller PHONE NO : 41 81 7506699
Gewerbestrasse 8 SE DECISION MADE: 13-SEP-19
Buchs SG CH 9470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PeraMobile and PeraWatch
PeraHealth, Inc. 510(k) NO: K183370(Traditional)
ATTN: Brad Coleman PHONE NO : 401 4000401
6302 Fairview Rd.,Suite 310 SE DECISION MADE: 11-SEP-19
Charlotte NC 28210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novidia Universal Bond
Nobio Ltd. 510(k) NO: K183391(Traditional)
ATTN: Inbal Beinglass Peled PHONE NO : 972 9 7893000
8 Hamatechet St. SE DECISION MADE: 24-SEP-19
Kadima IL 6092000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rhino-Laryngo Videoscope Olympus ENF-VT3
Olympus Medical Systems Corp. 510(k) NO: K183416(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 06-SEP-19
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA III Bronchovideoscope Olympus BF-XT190
Olympus Medical Systems Corp. 510(k) NO: K183419(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 05-SEP-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Ultrasonic Endoscope
Fujifilm Corporation 510(k) NO: K183433(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 05-SEP-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OraCure
TBM Corporation 510(k) NO: K183436(Traditional)
ATTN: Jae-woong Jeong PHONE NO : 82 2 9712845
B-301, Gwangju High-tech Center, 3SE DECISION MADE: 18-SEP-19
Gwangju KR 61008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geomed Vascular Dilators
Geomed Medizin-Technik GmbH & Co. 510(k) NO: K183438(Traditional)
ATTN: Hanno Haug PHONE NO : 011 497461 93550
Ludwigstaler Strasse 27 SE DECISION MADE: 03-SEP-19
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
Cenorin, LLC 510(k) NO: K183444(Traditional)
ATTN: Jenette A. Bennett PHONE NO : 253 3952400
6324 South 199th Place Suite 107 SE DECISION MADE: 09-SEP-19
Kent WA 98032 510(k) STATEMENT
DEVICE: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
PENTAX of America, Inc. 510(k) NO: K183516(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 06-SEP-19
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CNAP Monitor
CNSystems Medizintechnik GmbH 510(k) NO: K183521(Traditional)
ATTN: Bernd Wellisch PHONE NO : 0043 7 234560
Reininghausstrasse 13 SE DECISION MADE: 11-SEP-19
Graz AT 8020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
Olympus Medical Systems Corp. 510(k) NO: K183525(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 06-SEP-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Holinwon 30
Won Tech Co., Ltd. 510(k) NO: K183563(Traditional)
ATTN: Jake Yu PHONE NO : 82 70 78366921
64 Techno 8-Ro, Yuseong-gu SE DECISION MADE: 05-SEP-19
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
Huntleigh Healthcare Ltd 510(k) NO: K183574(Abbreviated)
ATTN: Steve Monks PHONE NO : 44 2920 485885
35 Portmanmoor Road SE DECISION MADE: 06-SEP-19
Cardiff GB CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapMedic
Cognita Labs, LLC 510(k) NO: K183586(Traditional)
ATTN: Rajoshi Biswas PHONE NO : 832 5383042
700 N Main St. Ste C1 SE DECISION MADE: 13-SEP-19
Santa Ana CA 92701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saline Wound Wash, SteriCleanse(TM)
Ascent Consumer Products, Inc. 510(k) NO: K183662(Traditional)
ATTN: Matthew Kornberg PHONE NO : 631 7551155
105 Baylis Road SE DECISION MADE: 12-SEP-19
Melville NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
Jiangsu Micsafe Medical Technology510(k) NO: K183665(Traditional)
ATTN: Tony Yang PHONE NO : 086 1365 1929266
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 06-SEP-19
Yancheng CN 224125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
Visco Vision Inc 510(k) NO: K183670(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 13-SEP-19
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Visualization System
Scivita Medical Technology Co., Lt510(k) NO: K183675(Traditional)
ATTN: Ruqin Wu PHONE NO : 86 512 81877788
No.8, Zhong Tian Xiang, Suzhou IndSE DECISION MADE: 25-SEP-19
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeWindow LW8 Lite
Digicare Biomedical Technology, In510(k) NO: K183687(Traditional)
ATTN: Eduardo Miranda PHONE NO : 1 561 6890408
107 Commerce Rd. SE DECISION MADE: 25-SEP-19
Boynton Beach FL 33426 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoAnalysis Software
Inteware Co., Ltd. 510(k) NO: K183695(Traditional)
ATTN: Wayne Tsai PHONE NO : 886 965 111210
4F., No.93, Xinzheng 5th St., TaiwSE DECISION MADE: 12-SEP-19
Minxiong Township, Chiayi Country 510(k) STATEMENT
DEVICE: Poly Clear
Medtek Skincare, LLC 510(k) NO: K183708(Traditional)
ATTN: Gary Richardson PHONE NO : 518 7473310
3 Depot Street SE DECISION MADE: 17-SEP-19
Hudson Falls NY 12839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Supercath 5
TOGO MEDIKIT Co., Ltd. 510(k) NO: K190001(Traditional)
ATTN: Daisuke Nagamizu PHONE NO : 011 81 982538000
17148-6 Aza Kamekawa, Oaza HichiyaSE DECISION MADE: 20-SEP-19
Hyuga City JP 883-0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
Shanghai Kohope Medical Devices Co510(k) NO: K190002(Traditional)
ATTN: Yibing Wang PHONE NO : 86 21 60836369
Room 1001, No.2 building, Lane 288SE DECISION MADE: 12-SEP-19
Shanghai CN 200331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
Sterilucent, Inc. 510(k) NO: K190005(Traditional)
ATTN: Peter Kalkbrenner PHONE NO : 612 7673253
1400 Marshall St. NE SE DECISION MADE: 13-SEP-19
Minneapolis MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeBreath Filter Mouthpiece
MD Diagnostics Limited 510(k) NO: K190022(Traditional)
ATTN: Glen Hillsley PHONE NO : 440 1622 682686
15 Hollingworth Court, Turkey MillSE DECISION MADE: 25-SEP-19
Maidstone GB ME14 5pp 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart-C
Turner Imaging Systems, Inc. 510(k) NO: K190024(Abbreviated)
ATTN: Michael Drake PHONE NO : 801 7962951
1119 South 1680 West SE DECISION MADE: 27-SEP-19
Orem UT 84058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
Changzhou Xin Neng Yuan Medical St510(k) NO: K190029(Traditional)
ATTN: Boping Ma PHONE NO : 86 519 88830515
No. 51 Shuishan Road, Zhonglou EcoSE DECISION MADE: 26-SEP-19
Changzhou CN 213023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UF(II) Anatomic abutment
DIO Corporation 510(k) NO: K190048(Traditional)
ATTN: Jiae Park PHONE NO : 82 51 7457836
66, Centum Seo-ro, Haeundae-gu SE DECISION MADE: 30-SEP-19
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sim&Size
Sim&Cure 510(k) NO: K190049(Traditional)
ATTN: Krishna Mahadea PHONE NO : 33 09 53405182
1682 Rue de la Valsiere SE DECISION MADE: 17-SEP-19
Grabels FR 34790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREC Guides
Dentsply Sirona 510(k) NO: K190059(Traditional)
ATTN: Karl J. Nittinger PHONE NO : 717 8494424
221 West Philadelphia St., Suite 6SE DECISION MADE: 27-SEP-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
Cepheid 510(k) NO: K190076(Traditional)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 27-SEP-19
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USTAR II System
United Orthopedic Corporation 510(k) NO: K190100(Traditional)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 23-SEP-19
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SepaSperm Washing Solution, SepaSperm Solution
Kitazato Corporation 510(k) NO: K190199(Traditional)
ATTN: Futoshi Inoue PHONE NO : 81 545 662202
81 Nakajima SE DECISION MADE: 26-SEP-19
Fuji-shi JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yikang Endotracheal Tube
Jiangxi Yikang Medical Instrument 510(k) NO: K190213(Traditional)
ATTN: Nicholas Su PHONE NO : 86 791 85632226
188 Aihua Road, Jinxian County SE DECISION MADE: 06-SEP-19
Nanchang CN 331725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microscope Navigation
Brainlab AG 510(k) NO: K190250(Special)
ATTN: Alexander Schwiersch PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 06-SEP-19
Munich DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Tenodesis Button
Arthrex Inc. 510(k) NO: K190288(Traditional)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 13-SEP-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
AMD Medicom, Inc. 510(k) NO: K190308(Traditional)
ATTN: Ronald Reuben PHONE NO : 514 6366262
2555 Chemin de l'Aviation, Pointe-SE DECISION MADE: 17-SEP-19
Montreal CA H9P 2Z2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aloe Glide Lubricant
Desert Harvest, Inc 510(k) NO: K190323(Traditional)
ATTN: Heather Florio PHONE NO : 919 2451853
437 Dimmocks Mill Rd Suite 17b SE DECISION MADE: 25-SEP-19
Hillsborough NC 27278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GM501 Wash
Hamilton Thorne, Inc. 510(k) NO: K190383(Traditional)
ATTN: Donald Fournier PHONE NO : 1 978 2050
100 Cummings Center, Suite 465E SE DECISION MADE: 05-SEP-19
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Republic Spine Restore Intervertebral Body Fusion System
Republic Spine LLC 510(k) NO: K190398(Traditional)
ATTN: James Doulgeris PHONE NO : 561 3628094
350 Camino Gardens Blvd Suite 103 SE DECISION MADE: 12-SEP-19
Boca Raton FL 33432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
Ever Global (Vietnam) Enterprise C510(k) NO: K190403(Third Party - Abbreviated)
ATTN: Jerry Lin PHONE NO : 84 61 3514022
No.1 Road, Long Thanh Industrial ZSE DECISION MADE: 06-SEP-19
Long Tanh District VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff
Hartalega Ngc Sdn. Bhd. 510(k) NO: K190454(Traditional)
ATTN: Kuan Kam Hon PHONE NO : 603 62771733
Dataran Sd Pju 9 SE DECISION MADE: 26-SEP-19
Bandar Sri Damansara MY 52200 510(k) STATEMENT
DEVICE: PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
Shen Wei USA Inc. 510(k) NO: K190466(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 26-SEP-19
Union City CA 94587 510(k) STATEMENT
DEVICE: ACIST RXi System and Navvus II Catheter
ACIST Medical Systems, Inc. 510(k) NO: K190473(Traditional)
ATTN: Sherri Mellingen PHONE NO : 952 9959300
7905 Fuller Road SE DECISION MADE: 13-SEP-19
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRA Open Matrix ALIF and LLIF
Camber Spine Technologies 510(k) NO: K190483(Traditional)
ATTN: Erin Kriebel PHONE NO : 484 4277060
501 Allendale Road SE DECISION MADE: 23-SEP-19
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BH Medical Dental Barrier Sleeves and Barrier Film
BH Medical Products Co., Ltd. 510(k) NO: K190484(Traditional)
ATTN: Xiaohua TAO PHONE NO : 86 519 83978705
No.90 Shenjiang Villagers' group, SE DECISION MADE: 10-SEP-19
Changzhou CN 213024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gem FlowCoupler System
Baxter/ Synovis Micro Companies Al510(k) NO: K190499(Traditional)
ATTN: Julie Carlston PHONE NO : 651 7967511
2875 University Ave. West SE DECISION MADE: 06-SEP-19
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Automatic (NIBP) Blood Pressure Monitor
Health & Life Co. ltd. 510(k) NO: K190507(Traditional)
ATTN: J.S. Hsu PHONE NO : 886 2 82271300 1201
9F, No. 186 Jian Yi Road SE DECISION MADE: 16-SEP-19
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
CarboFix Orthopedics Ltd. 510(k) NO: K190526(Traditional)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 19-SEP-19
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mediracer NCS
Mediracer Oy 510(k) NO: K190536(Traditional)
ATTN: Lassi Laitinen PHONE NO : 358 400 148881
Rantakatu 4 SE DECISION MADE: 25-SEP-19
Oulu FI 90100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
Solco Biomedical Co., Ltd. 510(k) NO: K190563(Traditional)
ATTN: Il Kim PHONE NO : 82 31 6644101
154 Seotan-ro, Seotan-myeon SE DECISION MADE: 18-SEP-19
Pyeongtaek KR 17704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Assistant Model PA97000
Medtronic, Inc 510(k) NO: K190574(Traditional)
ATTN: Cheryl Swanson PHONE NO : 763 5140088
8200 Coral Sea Street NE SE DECISION MADE: 24-SEP-19
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encompass 15 Channel Head Coil, 3T
Qfix 510(k) NO: K190668(Traditional)
ATTN: Alexandra Low Smythe PHONE NO : 610 2680585 736
440 Church Road SE DECISION MADE: 09-SEP-19
Avondale PA 19311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: External Counterpulsation System
Vamed Medical Instrument Co., Ltd 510(k) NO: K190683(Traditional)
ATTN: Ji Mia PHONE NO : 86 757 83817601
1 of 8 Floor, 2# Building, No. 60,SE DECISION MADE: 10-SEP-19
Foshan CN 528000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccelFix Lumbar Interbody Fusion Cage System
L&K Biomed Co., Ltd. 510(k) NO: K190708(Traditional)
ATTN: Jihyeon Seo PHONE NO : 82 2 67171983
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 16-SEP-19
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opus Bulk Fill APS, Opus Bulk Fill Flow APS
DentsCare LTDA 510(k) NO: K190758(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47 34416131
Av. Edgar Nelson Meister, 474 SE DECISION MADE: 04-SEP-19
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS icono
Siemens Medical Solutions USA, Inc510(k) NO: K190768(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard 65-1A SE DECISION MADE: 12-SEP-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo Application Software
Siemens Medical Solution USA, Inc.510(k) NO: K190780(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard 65-1A SE DECISION MADE: 12-SEP-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainScope TBI
BrainScope Company, Inc. 510(k) NO: K190815(Traditional)
ATTN: Michael Singer PHONE NO : 240 7527680
4330 East West Highway, Suite #100SE DECISION MADE: 11-SEP-19
Bethesda MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDM Screw Systems
TDM Co. Ltd. 510(k) NO: K190830(Traditional)
ATTN: Youngdae Kim PHONE NO : 82 62 6027460
69, Cheomdan Venture so-ro, 37 beoSE DECISION MADE: 13-SEP-19
Gwangju KR 61003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCENARIA View
Hitachi Healthcare Americas 510(k) NO: K190841(Traditional)
ATTN: Aaron Pierce PHONE NO :
1959 Summit Commerce Park SE DECISION MADE: 13-SEP-19
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Akesis Galaxy
Akesis Inc 510(k) NO: K190844(Traditional)
ATTN: Christopher Brown PHONE NO : 925 4081381
5129 Commercial Circle SE DECISION MADE: 04-SEP-19
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeeFactorCT3
Epica International Inc. 510(k) NO: K190856(Traditional)
ATTN: Daniel Naimey PHONE NO : 425 9417365
2753 Camino Capistrano. Suite A-10SE DECISION MADE: 20-SEP-19
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
United Consortium 510(k) NO: K190858(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 18-SEP-19
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Aeon Technology Co., Ltd.510(k) NO: K190869(Traditional)
ATTN: Xie Hua PHONE NO : 86 1390 2955475
RM6H02, Block 27-29, Tianxia IC InSE DECISION MADE: 13-SEP-19
Shenzhen CN 518052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
D.O.R.C. Dutch Ophthalmic Research510(k) NO: K190875(Traditional)
ATTN: Linda Van Leeuwen PHONE NO : 31 181 458080
B.V. Scheijdelveweg 2 SE DECISION MADE: 25-SEP-19
Zuidland NL 3214 VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: bili-hut
Little Sparrows Technologies, Inc.510(k) NO: K190899(Traditional)
ATTN: Erica Konston PHONE NO : 410 7031406
176 Mystic Valley Parkway SE DECISION MADE: 05-SEP-19
Winchester MA 01890 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmarTemp X1
Parkell, Inc. 510(k) NO: K190930(Traditional)
ATTN: David Mott PHONE NO : 631 3891134
300 Executive Drive SE DECISION MADE: 05-SEP-19
Edgewood NY 11717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RFID Localization System
Health Beacons, Inc. 510(k) NO: K190932(Traditional)
ATTN: Nancy Confrey PHONE NO : 978 2874635
34 Walden St. #753 SE DECISION MADE: 13-SEP-19
Concord MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advocate Non-Contact Infrared Thermometer
BroadMaster Biotech, Corp. 510(k) NO: K191004(Traditional)
ATTN: Jen Ke-Min PHONE NO : 886 3 4517600
1F., 2F., No. 91, Xiyuan Rd., ZhonSE DECISION MADE: 05-SEP-19
Taoyuan TW 32057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasiSlush
Bridge to Life Ltd. 510(k) NO: K191006(Traditional)
ATTN: Tom Keller PHONE NO : 803 5450080
128 Suber Rd. Suite A SE DECISION MADE: 24-SEP-19
Columbia SC 29210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
Welch Allyn, Inc. 510(k) NO: K191013(Traditional)
ATTN: Megan Pellenz PHONE NO : 414 3541600
7865 North 86th St. SE DECISION MADE: 10-SEP-19
Milwaukee WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
Terragene SA 510(k) NO: K191021(Traditional)
ATTN: Maria Victoria Rocha PHONE NO : 54 341 5587007
Ruta Nacional No. 9, Km 280, ParquSE DECISION MADE: 13-SEP-19
Alvear AR 2130 510(k) STATEMENT
DEVICE: VPS Impression Material
Hygedent Inc. 510(k) NO: K191034(Traditional)
ATTN: Peng Wang PHONE NO : 010 139 01284956
Room 210C, Building 4, No 5 ChaoqiSE DECISION MADE: 04-SEP-19
Beijing CN 102299 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signia Small Diameter Reloads
Covidien 510(k) NO: K191070(Traditional)
ATTN: Frank Gianelli PHONE NO : 203 4925352
60 Middletown Avenue SE DECISION MADE: 04-SEP-19
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sorrento Bone Graft Substitute
Xenco Medical, LLC 510(k) NO: K191074(Traditional)
ATTN: Jason Haider PHONE NO : 858 2021505
9930 Mesa Rim Road SE DECISION MADE: 27-SEP-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precision S 4K Sinuscope
Stryker 510(k) NO: K191102(Traditional)
ATTN: Jessie Duong PHONE NO : 408 7542077
5900 Optical Court SE DECISION MADE: 06-SEP-19
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEHC DXA Bone Densitometers with enCORE version 18
GE Medical Systems Ultrasound & Pr510(k) NO: K191112(Traditional)
ATTN: Martha Kamrow PHONE NO : 262 5482573
3030 Ohmeda Drive SE DECISION MADE: 19-SEP-19
Madison WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: geko T-2 and geko T-3 Neuromuscular Stimulators
Firstkind Limited 510(k) NO: K191113(Traditional)
ATTN: Neil Buckley PHONE NO : 44 01494 572040
Hawk House, Peregrine Business ParSE DECISION MADE: 18-SEP-19
High Wycombe GB HP13 7DL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
Lentechs, LLC 510(k) NO: K191121(Traditional)
ATTN: Robin Sears PHONE NO : 614 4873700
1275 Kinnear Road SE DECISION MADE: 06-SEP-19
Columbus OH 43212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K191148(Traditional)
ATTN: Shweta Sharma PHONE NO : 901 3992425
1800 Pyramid Place SE DECISION MADE: 12-SEP-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Myo Plus
Otto Bock Healthcare Products GmbH510(k) NO: K191179(Traditional)
ATTN: Rene Urtz PHONE NO : 43 1 5233786707
Brehmstrabe 16 1110 Wien SE DECISION MADE: 04-SEP-19
Vienna AT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dornier MINNOW Ureteral Catheter
Dornier MedTech America Inc 510(k) NO: K191187(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd, Suite 100 SE DECISION MADE: 18-SEP-19
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
Medos International SARL 510(k) NO: K191212(Traditional)
ATTN: Sergio M. Cordeiro PHONE NO : 508 9772640
Chemin-Blanc 38 SE DECISION MADE: 24-SEP-19
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuCath Ace Intravascular Catheter
C.R. Bard, Inc 510(k) NO: K191232(Traditional)
ATTN: Mona Shahrebani PHONE NO : 801 5225967
605 North 5600 West SE DECISION MADE: 18-SEP-19
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEDRON Cervical Spacers
Globus Medical Inc. 510(k) NO: K191243(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 17-SEP-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable NIBP Cuff
Shenzhen Changke Connect Electroni510(k) NO: K191253(Traditional)
ATTN: Yahui Zhou PHONE NO : 86 13 613012560
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 17-SEP-19
Longgang District, Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Link X2 ECG and SpO2 Adapter
Vyaire Medical, Inc. 510(k) NO: K191273(Traditional)
ATTN: Suzanne Moreno PHONE NO : 872 7570147
26125 N. Riverwoods Blvd. SE DECISION MADE: 13-SEP-19
Mettawa IL 60630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transvaginal Access Platform
Applied Medical Resources Corp. 510(k) NO: K191294(Traditional)
ATTN: Corinne Yestrepsky PHONE NO : 949 7138176
22872 Avenida Empresa SE DECISION MADE: 06-SEP-19
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNSitu Bipolar Hip System
Theken Companies, LLC 510(k) NO: K191297(Traditional)
ATTN: Garrett Spurgeon PHONE NO : 330 7337600 1632
1800 Triplett Blvd SE DECISION MADE: 17-SEP-19
Akron OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLock Ti Suture Anchor
Medacta International SA 510(k) NO: K191300(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 12-SEP-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceribell Pocket EEG Device
Ceribell, Inc. 510(k) NO: K191301(Traditional)
ATTN: Josef Parvizi PHONE NO : 650 5217003
2483 Old Middlefield Way, Suite 12SE DECISION MADE: 11-SEP-19
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CivaDerm
CivaTech Oncology Inc. 510(k) NO: K191324(Traditional)
ATTN: Suzanne Babcock PHONE NO : 919 3145515
2810 Meridian Parkway, Suite 152 SE DECISION MADE: 20-SEP-19
Durham NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE System
NuVasive Specialized Orthopedics, 510(k) NO: K191336(Traditional)
ATTN: Aditya Sharma PHONE NO : 858 4800263
101 Enterprise, Suite 100 SE DECISION MADE: 26-SEP-19
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
STERIS Corporation 510(k) NO: K191343(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 05-SEP-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ti3Z Cervical Interbody System
Zavation Medical Products, LLC 510(k) NO: K191354(Traditional)
ATTN: Katie Motley PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 09-SEP-19
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
3M Health Care 510(k) NO: K191355(Traditional)
ATTN: Angie Draper PHONE NO : 651 7331179
3M Center, 2510 Conway Ave., BuildSE DECISION MADE: 11-SEP-19
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy-America, Inc.510(k) NO: K191357(Traditional)
ATTN: Irina Fedorov PHONE NO : 508 2481275
2151 E. Grand Avenue SE DECISION MADE: 18-SEP-19
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vacutore Air/Water Bottle Tubing
Smartdata Suzhou Co., Ltd 510(k) NO: K191366(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 86 512 65983722
4f, Block 7, 198#, Jinshan Rd SE DECISION MADE: 06-SEP-19
Suzhou CN 215011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
Medline Industries, Inc. 510(k) NO: K191378(Traditional)
ATTN: Stephanie Augsburg PHONE NO : 847 6433690
Three Lake Drive SE DECISION MADE: 15-SEP-19
Northfield IL 60093 510(k) STATEMENT
DEVICE: HEDRON Lumbar Spacers
Globus Medical Inc. 510(k) NO: K191391(Traditional)
ATTN: Kelly Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 18-SEP-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K191392(Traditional)
ATTN: Karla Schaffner PHONE NO : 1 442 2326161
2210 Faraday Ave., Suite 100 SE DECISION MADE: 06-SEP-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
Rex Medical, L.P. 510(k) NO: K191419(Traditional)
ATTN: Colin Valentis PHONE NO : 610 9400665
555 East North Lane, Suite 5035 SE DECISION MADE: 12-SEP-19
Conshohocken PA 19428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sofacia System
Sofwave Medical Ltd. 510(k) NO: K191421(Traditional)
ATTN: Ruthie Amir PHONE NO : 972 54 3003164
Beit Tavor 2 SE DECISION MADE: 09-SEP-19
Yokneam IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
Nalu Medical, Inc. 510(k) NO: K191435(Traditional)
ATTN: Michele Chin-Purcell PHONE NO : 760 8276461
2320 Faraday Ave. Suite 100 SE DECISION MADE: 06-SEP-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
Medtronic, Inc. 510(k) NO: K191444(Traditional)
ATTN: Harsh Dharamshi PHONE NO : 763 5058646
7611 Northland Drive SE DECISION MADE: 27-SEP-19
Minneapolis MN 55428 510(k) STATEMENT
DEVICE: BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
MED-EL Elektromedizinische Geraete510(k) NO: K191457(Traditional)
ATTN: Ines Roman Santiago PHONE NO : 43 57 7885786
Fuestenweg 77a SE DECISION MADE: 18-SEP-19
Innsbruck AT 6020 510(k) STATEMENT
DEVICE: JuggerStitch Meniscal Repair Device
Biomet Inc. 510(k) NO: K191459(Traditional)
ATTN: Kyle Ponce PHONE NO : 973 2999300 2125
56 East Bell Drive SE DECISION MADE: 13-SEP-19
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® ACP System
NuVasive, Incorporated 510(k) NO: K191500(Traditional)
ATTN: Jessica Silverman PHONE NO : 858 9093302
7475 Lusk Blvd. SE DECISION MADE: 03-SEP-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MobileRay Pulse SE Digital Imaging System
Portavision Medical LLC 510(k) NO: K191503(Traditional)
ATTN: Terry Ancar PHONE NO : 866 7834133
800 Central Avenue SE DECISION MADE: 04-SEP-19
Jefferson LA 70121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ali Interbody Fusion System
Raed M. Ali, MD., Inc. 510(k) NO: K191516(Traditional)
ATTN: Raed Ali PHONE NO :
6 Starcatcher SE DECISION MADE: 12-SEP-19
Newport Coast CA 92657 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 Laser System
Shenzhen GSD Tech Co., Ltd 510(k) NO: K191518(Traditional)
ATTN: Jiancheng Zhang PHONE NO : 86 755 29169426
Building A Junsd Hi-Tech Park, WesSE DECISION MADE: 12-SEP-19
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radiance 330 Proton Beam Therapy System
ProTom International Holding Corpo510(k) NO: K191521(Traditional)
ATTN: Stephen L. Spotts PHONE NO : 781 2453964
500 Edgewater Place Suite 522 SE DECISION MADE: 27-SEP-19
Wakefield MA 01880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visalys Tooth Primer
Kettenbach GmbH & Co. KG 510(k) NO: K191524(Traditional)
ATTN: Katja Simon PHONE NO : 49 2774 7050
Im Heerfeld 7 SE DECISION MADE: 29-SEP-19
Eschenburg DE 35713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Legacy Pro Device
Venus Concept USA Inc. 510(k) NO: K191528(Traditional)
ATTN: Yoni Iger PHONE NO : 972 549599215
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 06-SEP-19
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StoneChecker
Imaging Biometrics, LLC 510(k) NO: K191530(Traditional)
ATTN: Timothy Dondlinger PHONE NO : 262 4398252
13416 Watertown Plank Road, Suite SE DECISION MADE: 26-SEP-19
Elm Grove WI 53122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sure-Fine Insulin Syringes
Shina Med Corporation 510(k) NO: K191531(Special)
ATTN: Park Sung-soon PHONE NO : 82 31 80572125
455-30 Bogaewonsam-ro, Bogae-myun SE DECISION MADE: 06-SEP-19
Anseong-si KR 456-871 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eCarbon IBDs
Back 2 Basics Direct, LLC 510(k) NO: K191537(Traditional)
ATTN: Scot Miller PHONE NO : 216 4475205
6701 Rockside Road, Suite 200 SE DECISION MADE: 26-SEP-19
Independence OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exogenesis Hernia Mesh
Exogenesis Corporation 510(k) NO: K191545(Traditional)
ATTN: Joseph Khoury PHONE NO : 978 4390120
20 Fortune Drive SE DECISION MADE: 26-SEP-19
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GM501 Mineral Oil
Hamilton Thorne Inc. 510(k) NO: K191552(Abbreviated)
ATTN: Donald Fournier PHONE NO : 1 978 9212050
100 Cummings Center, Suite 465E SE DECISION MADE: 18-SEP-19
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mercury® Spinal System, Overwatch® Spinal System
Spinal Elements, Inc 510(k) NO: K191576(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071840
3115 Melrose Dr. Suite 200 SE DECISION MADE: 16-SEP-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Willow Wearable Breast Pump 2.0
Exploramed NC7, Inc. 510(k) NO: K191577(Special)
ATTN: Steve Holmes PHONE NO : 650 5595805
1975 W. El Camino Real, Suite 306 SE DECISION MADE: 06-SEP-19
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L360 Thigh System
Bioness Inc. 510(k) NO: K191587(Traditional)
ATTN: Mercedes Bayani PHONE NO : 661 3626690
25103 Rye Canyon Loop SE DECISION MADE: 12-SEP-19
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Di510(k) NO: K191595(Traditional)
ATTN: Judi Wallach PHONE NO : 224 6671132
Dept. 09AA, Bldg. AP8, 100 Abbott SE DECISION MADE: 13-SEP-19
Abbott Park IL 60064-6038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICO Myriad NOVUS
NICO Corporation 510(k) NO: K191599(Traditional)
ATTN: Sean Spence PHONE NO : 317 6607118 115
250 East 96th Street, Suite 125 SE DECISION MADE: 13-SEP-19
Indianapolis IN 46240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS)
Neocis Inc. 510(k) NO: K191605(Traditional)
ATTN: Thomas E. Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 11-SEP-19
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntec Tibial Nail System
Syntec Scientific Corporation 510(k) NO: K191617(Traditional)
ATTN: Kavin Chu PHONE NO : 886 4 7987099
No.2, Kung San Road Chuan Shing InSE DECISION MADE: 03-SEP-19
Chang Hua TW 50971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TurboTemp EZ
Zest Anchors, LLC 510(k) NO: K191619(Traditional)
ATTN: Marysa E. Loustalot PHONE NO : 760 7437744
2875 Loker Avenue East SE DECISION MADE: 11-SEP-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona Revision Knee System
Zimmer Inc. 510(k) NO: K191625(Traditional)
ATTN: Nicole Meredith PHONE NO : 574 3773718
1800 W. Center Street SE DECISION MADE: 05-SEP-19
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: faceLITE
iSMART Marketing Svcs Ltd 510(k) NO: K191629(Traditional)
ATTN: Susan D'Arcy PHONE NO : 44 07880 313315
129 Green Lanes, Sutton Coldfield SE DECISION MADE: 12-SEP-19
Birmingham GB B735LT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws
Industrias Medicas Sampedro S.A.S 510(k) NO: K191641(Traditional)
ATTN: Liliana Zuluaga-Idarraga PHONE NO : 574 3223375
Carrera 47 No. 100 Sur 40 SE DECISION MADE: 16-SEP-19
La Estrella CO 055468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
Canon Medical Systems Corporation 510(k) NO: K191663(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 18-SEP-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intra.Ox 2.0 Handheld Tissue Oximeter
ViOptix, Inc. 510(k) NO: K191676(Traditional)
ATTN: Scott Coleridge PHONE NO : 510 2265860
39655 Eureka Drive SE DECISION MADE: 16-SEP-19
Newark CA 94560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnipod DASH Insulin Management System with interoperable technology
Insulet Corporation 510(k) NO: K191679(Traditional)
ATTN: Julie Perkins PHONE NO : 987 6007951
100 Nagog Park SE DECISION MADE: 20-SEP-19
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoWay Laser System
Candela Corporation 510(k) NO: K191685(Traditional)
ATTN: Brenda Geary PHONE NO : 508 9743556
530 Boston Post Road SE DECISION MADE: 16-SEP-19
Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SubtleMR
Subtle Medical, Inc. 510(k) NO: K191688(Traditional)
ATTN: Ajit Shankaranarayanan PHONE NO : 650 3978709
883 Santa Cruz Ave, Suite 205 SE DECISION MADE: 16-SEP-19
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Retrieval/Aspiration System
Inari Medical 510(k) NO: K191710(Traditional)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 05-SEP-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Buhlmann fCAL turbo and CALEX Cap
BUHLMANN Laboratories AG 510(k) NO: K191718(Traditional)
ATTN: Laura Zurbrugg PHONE NO : 41 61 4871250
Baselstrasse 55 SE DECISION MADE: 24-SEP-19
Schonenbuch CH 4124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: mont blanc & mont blanc MIS Spinal Systems
Spineway SA 510(k) NO: K191726(Traditional)
ATTN: Heloise Macaire PHONE NO : 33 04 72770152
7 allee Moulin Berger SE DECISION MADE: 12-SEP-19
Ecully FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIES MRSA Assay
Luminex Corporation 510(k) NO: K191742(Traditional)
ATTN: Kate Linak PHONE NO : 608 2038909
12212 Technology Blvd SE DECISION MADE: 25-SEP-19
Austin TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Duodenoscope Model ED-580XT
FUJIFILM Corporation 510(k) NO: K191747(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 27-SEP-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine Sacroiliac Joint Fusion System
Genesys Spine 510(k) NO: K191748(Traditional)
ATTN: William W. Sowers PHONE NO : 512 3817080
1250 South Capital of Texas HighwaSE DECISION MADE: 26-SEP-19
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI TiN Coated Apex Knee™ System
OMNI life science, Inc. 510(k) NO: K191765(Traditional)
ATTN: Christina Rovaldi PHONE NO : 774 2261857
480 Paramount Drive SE DECISION MADE: 25-SEP-19
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmileAlign Orthodontic Aligner System
3D Global Biotech Inc. 510(k) NO: K191774(Traditional)
ATTN: Keng-Liang Ou PHONE NO : 886 2 26971270
21F.-1, No.99, Sec. 1, Xintai 5th SE DECISION MADE: 30-SEP-19
New Taipei City 221 TW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TTC Phantom Intramedullary Nail System
Paragon 28, Inc. 510(k) NO: K191782(Special)
ATTN: Eric Lintula PHONE NO : 888 7281888
4B Inverness Ct. E., STE 280 SE DECISION MADE: 06-SEP-19
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TranS1 Interbody Fusion System
TranS1 510(k) NO: K191791(Traditional)
ATTN: Kristen Allen PHONE NO : 888 5261879
3804 Park Avenue, Suite C SE DECISION MADE: 25-SEP-19
Wilmington NC 28403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
Kossan International Sdn. Bhd. 510(k) NO: K191800(Traditional)
ATTN: Cho Sow Fong PHONE NO : 603 3 2910516
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 16-SEP-19
Klang MY 42100 510(k) STATEMENT
DEVICE: PROBEAT-CR
Hitachi Ltd. 510(k) NO: K191801(Traditional)
ATTN: Tomoyuki Seino PHONE NO : 81 294 555900
3-1-1, Saiwai-cho SE DECISION MADE: 13-SEP-19
Hitachi-shi JP 317-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst OrthoScience CSR Shoulder System
Catalyst OrthoScience, Inc. 510(k) NO: K191811(Special)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 11-SEP-19
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Quanta System, S.p.A. 510(k) NO: K191842(Traditional)
ATTN: Francesco Dell’Antonio PHONE NO : 39 0331 376797
Via Acquedotto, 109 SE DECISION MADE: 17-SEP-19
Samarate IT 20826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fidmi Low Profile Enteral Feeding Device
Fidmi Medical Ltd 510(k) NO: K191844(Traditional)
ATTN: Shahar Millis PHONE NO : 972 77 3628362
5 Haeshel St. SE DECISION MADE: 30-SEP-19
Caesarea Business Park, Caesarea 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
Barco NV 510(k) NO: K191845(Traditional)
ATTN: Julie Vandecandelaere PHONE NO : 32 56 262319
President Kennedypark 35 SE DECISION MADE: 06-SEP-19
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS Wrist Spanning Plates 2.5
Medartis AG 510(k) NO: K191848(Traditional)
ATTN: Andrea Schweizer PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 30-SEP-19
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual-Safety Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K191853(Traditional)
ATTN: Zearou Yang PHONE NO : 865 718 8772985
Bldg. 1, No. 12, Longtan Road, CanSE DECISION MADE: 05-SEP-19
Hangzhou City CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Imipenem 0.016-256 µg/mL
Liofilchem s.r.l. 510(k) NO: K191908(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 04-SEP-19
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Hinged Laminoplasty System
Life Spine, Inc. 510(k) NO: K191927(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 20-SEP-19
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
UNICON Optical CO., LTD 510(k) NO: K191929(Traditional)
ATTN: Hsiao-Wei Shen PHONE NO : 886 3 5775586
No 16, Gongye E. 9th Rd. Hsinchu SSE DECISION MADE: 17-SEP-19
Hsinchu County TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOWA nonmyd 8
Kowa Company, Ltd. 510(k) NO: K191945(Traditional)
ATTN: Nariaki Morita PHONE NO : 81 42 4407612
3-1, Chofugaoka 3-Chome SE DECISION MADE: 10-SEP-19
Chofu JP 1820021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
Maquet Cardiovascular, LLC. 510(k) NO: K191947(Traditional)
ATTN: Mark Dinger PHONE NO : 973 7097691
45 Barbour Pond Drive SE DECISION MADE: 17-SEP-19
Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNFOLDER Vitan Inserter
Johnson & Johnson Surgical Vision,510(k) NO: K191949(Abbreviated)
ATTN: Silvia Jiang-Hughes PHONE NO : 714 2478714
1700 East Saint Andrew Place SE DECISION MADE: 13-SEP-19
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mako Total Hip Application, Mako Total Knee Application
MAKO Surgical Corp. 510(k) NO: K191998(Traditional)
ATTN: Shikha Khandelwal PHONE NO : 201 8316921
2555 Davie Road SE DECISION MADE: 24-SEP-19
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmoothSkin BARE+
CyDen Limited 510(k) NO: K192010(Special)
ATTN: Adam Stephens PHONE NO : 44 01792 274009
Block A, Bay Studios Business ParkSE DECISION MADE: 24-SEP-19
Swansea GB SA1 8QB 510(k) STATEMENT
DEVICE: PhoeniX
Sedecal, SA. 510(k) NO: K192011(Abbreviated)
ATTN: Mª Luisa Gomez de Aguero PHONE NO : 34 91 6280544
C/Pelaya, 9 -13 Pol. Ind. Rio de JSE DECISION MADE: 25-SEP-19
Algete ES 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capillus 112, Capillus 244
Capillus 510(k) NO: K192012(Special)
ATTN: Patricia Schnoor PHONE NO : 786 8881874
1715 NW 82nd Ave. SE DECISION MADE: 12-SEP-19
Doral FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
STERIS Corporation 510(k) NO: K192020(Special)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Road SE DECISION MADE: 05-SEP-19
Mentor OH 44077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K192030(Traditional)
ATTN: Ji Yea Lee PHONE NO : 82 2 21941594
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 19-SEP-19
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advisor VL Circular Mapping Catheter, Sensor Enabled
Abbott Medical 510(k) NO: K192037(Traditional)
ATTN: Tamara L. Stanczak PHONE NO : 651 7566656
5050 Nathan Lane North SE DECISION MADE: 17-SEP-19
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
bioMerieux SA 510(k) NO: K192050(Traditional)
ATTN: Marine Taravant PHONE NO : 33 04 78872126
376 Chemin de l’Orme SE DECISION MADE: 27-SEP-19
Marcy-l’Etoile FR 69280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio Guard Air/Water & Suction Valves
United States Endoscopy Group, Inc510(k) NO: K192059(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 17-SEP-19
Mentor OH 44060 510(k) STATEMENT
DEVICE: GOLNIT Non-aborbable PTFE Surgical Suture
Antarma LLC dba Golnit Sutures 510(k) NO: K192088(Special)
ATTN: Armine Badalyan PHONE NO : 718 2190731
276 5th Ave., Suite 704 SE DECISION MADE: 04-SEP-19
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermoplastic Masks
Aktina Medical Corporation 510(k) NO: K192102(Traditional)
ATTN: Tony Spaccarotella PHONE NO : 845 2680101 18
360 North Route 9W SE DECISION MADE: 25-SEP-19
Congers NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQRef Introducer Sheath
Acutus Medical, Inc. 510(k) NO: K192106(Special)
ATTN: Serena Sanginthirath PHONE NO : 1 442 2326178
2210 Faraday Ave., Suite 100 SE DECISION MADE: 03-SEP-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexBand Plus
International Life Sciences 510(k) NO: K192112(Special)
ATTN: Tiffini Wittwer PHONE NO : 707 7996732
2252 Northwest Parkway SE SE DECISION MADE: 27-SEP-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Human IgA liquid reagent kit for Use on SPAPlus
The Binding Site Group Ltd 510(k) NO: K192116(Special)
ATTN: Natasha Verhaak PHONE NO : 44 0121 4569500
8 Calthorpe Road Edgbaston SE DECISION MADE: 04-SEP-19
Birmingham GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Clarity Aligners
3M Company 510(k) NO: K192119(Third Party - Traditional)
ATTN: Yanine Garcia-Quezada PHONE NO : 651 7368238
2510 Conway Avenue SE DECISION MADE: 05-SEP-19
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
Qingdao Hightop Biotech Co., Ltd. 510(k) NO: K192123(Traditional)
ATTN: Allen Lee PHONE NO : 86 0532 58710705
No. 369 Hedong Road, Hi-tech IndusSE DECISION MADE: 05-SEP-19
Qingdao CN 266112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens
Clearlab SG Pte, Ltd 510(k) NO: K192129(Special)
ATTN: John Christopher Phelan PHONE NO : 65 6749 1090
139 Joo Seng Road #01-01 SE DECISION MADE: 27-SEP-19
Singapore SG 368362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freedom Primary PCK
Maxx Orthopedics, Inc. 510(k) NO: K192148(Special)
ATTN: Priscilla Herpai PHONE NO : 484 3420092
2460 General Armistead Ave. Suite SE DECISION MADE: 05-SEP-19
Norristown PA 19403 510(k) STATEMENT
DEVICE: Smith & Nephew DYONICS 25 Fluid Management System
Smith & Nephew, Inc. 510(k) NO: K192155(Special)
ATTN: Bryan Cowell PHONE NO : 978 7491093
150 Minuteman Road SE DECISION MADE: 04-SEP-19
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cartiva SCI instrumentation set
Cartiva, Inc. 510(k) NO: K192156(Special)
ATTN: Shriya Kafle PHONE NO : 770 7543800
6120 Windward Parkway, Suite 220 SE DECISION MADE: 04-SEP-19
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVO Platform
Quanta System, S.p.A 510(k) NO: K192160(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 033 1376797
Via Acquedotto, 109 SE DECISION MADE: 06-SEP-19
Samarate IT 20826 510(k) STATEMENT
DEVICE: Connected OR Hub with Device and Voice Control
Stryker 510(k) NO: K192172(Special)
ATTN: Meagan Jones PHONE NO : 214 7012186
5900 Optical Court SE DECISION MADE: 09-SEP-19
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion ONE (TSX-306A/3) V10.0
Canon Medical Systems Corporation 510(k) NO: K192188(Special)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 06-SEP-19
Otawara-Shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Dilator
Galt Medical Corp. 510(k) NO: K192195(Special)
ATTN: David Derrick PHONE NO : 972 2715177
2220 Merritt Dr. SE DECISION MADE: 26-SEP-19
Garland TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRC PC Smart Chamber K1
Capintec, Inc. 510(k) NO: K192199(Special)
ATTN: Mary Anne Yusko PHONE NO : 201 8259500 312
7 Vreeland Road SE DECISION MADE: 12-SEP-19
Florham Park NJ 07932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NCB Plating System Distal Femur and Proximal Tibia
Zimmer GmbH 510(k) NO: K192217(Special)
ATTN: Annemie Rehor Kausch PHONE NO : 41 58 8548261
Sulzerallee 8 SE DECISION MADE: 13-SEP-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumify Diagnostic Ultrasound System
Philips Healthcare 510(k) NO: K192226(Third Party - Traditional)
ATTN: Paul Elias PHONE NO : 425 4828396
22100 Bothell Everett Highway SE DECISION MADE: 06-SEP-19
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ProPerformance Recovery System
Menlo Brands LLC 510(k) NO: K192252(Third Party - Traditional)
ATTN: Sam Chi PHONE NO : 650 7968905
2045 Avy Avenue SE DECISION MADE: 19-SEP-19
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: InnoSight Diagnostic Ultrasound System
Qisda Corporation 510(k) NO: K192254(Third Party - Traditional)
ATTN: Johnson Sheu PHONE NO :
No.157, Shanying Rd, Shan-Ting Li,SE DECISION MADE: 18-SEP-19
Taoyuan TW 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Philips IntelliSite Pathology Solution
Philips Electronics Nederland B.V.510(k) NO: K192259(Special)
ATTN: Liselotte Kornmann PHONE NO : 31 6 11621238
Veenpluis 6 SE DECISION MADE: 20-SEP-19
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merge Cardio
Merge Healthcare Incorporated 510(k) NO: K192276(Traditional)
ATTN: Lisa Baumhardt PHONE NO : 262 3693364
900 Walnut Ridge Drive SE DECISION MADE: 20-SEP-19
Hartland WI 53209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uDR 592h, uDR 596i
Shanghai United Imaging Healthcare510(k) NO: K192293(Special)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
No. 2258 Chengbei Road, SE DECISION MADE: 12-SEP-19
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic 6F Taiga Guiding Catheter
Medtronic Vascular 510(k) NO: K192296(Special)
ATTN: Colleen Mullins PHONE NO : 978 7393267
37a Cherry Hill Drive SE DECISION MADE: 20-SEP-19
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K192301(Traditional)
ATTN: Wenhau Yan PHONE NO : 86 755 27948546
No.2-1,Liuxian 1st Road,Xin'an SubSE DECISION MADE: 20-SEP-19
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS Software Version 3.6.0
Surgical Information Sciences, Inc510(k) NO: K192304(Special)
ATTN: Ann Quinlan-Smith PHONE NO : 612 3250187
10405 6th Avenue North, Suite 110 SE DECISION MADE: 13-SEP-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Stat 2.0 Microvascular Tissue Oximeter
Spectros Corporation 510(k) NO: K192322(Special)
ATTN: Bill Curnan PHONE NO : 650 8514040
274 E Hamilton Ave Suite H SE DECISION MADE: 23-SEP-19
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyDisk AST Lefamulin 20µg (LMU20)
Hardy Diagnostics 510(k) NO: K192326(Traditional)
ATTN: Anna Klavins PHONE NO : 800 2662222 5752
1430 West McCoy Lane SE DECISION MADE: 19-SEP-19
Santa Maria CA 93455 510(k) STATEMENT
DEVICE: ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
Inari Medical 510(k) NO: K192332(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 20-SEP-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire NC Plus Coronary Dilatation Catheter
OrbusNeich Medical Trading Inc. 510(k) NO: K192344(Special)
ATTN: John Pazienza PHONE NO : 954 7300711
5363 NW 35th Avenue SE DECISION MADE: 19-SEP-19
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniMAX
Medacta International SA 510(k) NO: K192352(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 27-SEP-19
Castel San Pietro CH ch-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Innovasis Gibralt Spine System
Innovasis, Inc. 510(k) NO: K192354(Special)
ATTN: Marshall McCarthy PHONE NO : 801 2612236
614 East 3900 South SE DECISION MADE: 24-SEP-19
Salt Lake City UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GXR-Series Diagnostic X-Ray System
DRGEM Corporation 510(k) NO: K192364(Traditional)
ATTN: Ki-Nam Yang PHONE NO : 82 2 8698566
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 26-SEP-19
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATSmart
Fresenius Kabi AG 510(k) NO: K192368(Special)
ATTN: Shane Sawall PHONE NO : 49 6172 6860
Else-Kroner-Strasse 1 SE DECISION MADE: 27-SEP-19
Bad Homburg DE 61352 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioZorb SP Marker
Focal Therapeutics 510(k) NO: K192371(Special)
ATTN: Dhaval Saraiya PHONE NO : 408 9627010
1010 Stewart Drive SE DECISION MADE: 26-SEP-19
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectralis HRA+OCT and Variants
Heidelberg Engineering GmbH 510(k) NO: K192391(Special)
ATTN: Arianna Schoess Vargas PHONE NO : 49 6221 64630
Max-Jarecki-Strasse 8 SE DECISION MADE: 26-SEP-19
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc510(k) NO: K192402(Special)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 20-SEP-19
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiFaith Syringe
Flat Medical Co., Ltd 510(k) NO: K192421(Special)
ATTN: Shao Wei Tseng PHONE NO : 886 225672 959 13
9F-1., No27, Sec.1, Chang' An E. RSE DECISION MADE: 27-SEP-19
Taipei TW 10441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
Won Tech Co., Ltd. 510(k) NO: K192425(Special)
ATTN: Jake Yu PHONE NO : 82 707836 6921
64 Techno 8-Ro, Yuseong-gu SE DECISION MADE: 30-SEP-19
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive NuvaLine
NuVasive, Incorporated 510(k) NO: K192435(Third Party - Traditional)
ATTN: Manthan Damani PHONE NO : 858 9091800
7475 Lusk Boulevard SE DECISION MADE: 26-SEP-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 237
TOTAL WITH SUMMARIES 222
TOTAL WITH STATEMENTS 15
