| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K200078 |
04/10/2020 |
VARO Plan |
3D Industrial Imaging Co., Ltd. |
Myungsuk Park |
| K200092 |
04/15/2020 |
3MTM AttestTM Mini Auto-reader 490M |
3M |
Andrew Wingen |
| K200712 |
04/17/2020 |
Rumble Tuff Electric Breast Pump |
A Cute Baby, Inc. |
Matthew Kho |
| K200492 |
04/09/2020 |
i-STAT CG4+ Cartridge with the i-STAT 1 System |
Abbott point of Care, Inc. |
Susan Tibedo |
| K200144 |
04/08/2020 |
HI-TORQUE Steelcore Bare Guide Wire |
Abbott Vascular |
Shilpa Satishchandra |
| K200566 |
04/03/2020 |
ADAPT Tissue |
Admedus Regen Pty Ltd |
Kiran Bhirangi |
| K200300 |
04/13/2020 |
VivAer Stylus |
Aerin Medical Inc |
Matthew M Hull |
| K200361 |
04/06/2020 |
Akros Scruture Anchor LisFranc Repair Kit |
Akros Medical |
Charles Horrell |
| K193095 |
04/02/2020 |
Ambu aScope 4 Cysto |
Ambu A/S |
Anita Fjaestad |
| K191866 |
04/29/2020 |
GelPOINT Mini Advanced Access Platform |
Applied Medical |
Frans VandenBroek |
| K200598 |
04/08/2020 |
Voyant Maryland Fusion Device |
Applied Medical Resources Corp. |
Blake Stacy |
| K192786 |
04/25/2020 |
Gatekeeper Balloon Catheter |
Arch Catheter, LLC |
Michael Zhadkevich |
| K200634 |
04/09/2020 |
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit |
Arrow International Inc. |
Apurva N. Gokhale |
| K193523 |
04/30/2020 |
ArthrexVIP Web Portal |
Arthrex Inc. |
Heli F Chambi Infantas |
| K192492 |
04/21/2020 |
EL CAPITAN Anterior Lumber Interbody System |
Astura Medical, LLC |
Parker Kelch |
| K192006 |
04/02/2020 |
SIRION Lateral Lumbar Interbody System |
Astura Medical, LLC |
Parker Kelch |
| K193534 |
04/15/2020 |
Monarch Platform |
Auris Health, Inc. |
Anna Libman |
| K192676 |
04/01/2020 |
Introcan Safety 2 IV Catheter 18-24 gauge |
B. Braun Medical Inc. |
Tracy Larish |
| K200266 |
04/07/2020 |
BD Centro Vena Acute Central Line (7 French Dual Lumen) |
Bard Access Systems, Inc. (Bard has joined BD) |
Breanna Casados |
| K191654 |
04/14/2020 |
SILICONE Personal Lubricant |
Bath Concept Cosmetics (Dongguan) Co., Ltd |
Jack Yin |
| K191353 |
04/14/2020 |
COMET Lumbar Interbody Fusion Cage |
BAUI Biotech Co., Ltd. |
Jessy Lin |
| K193124 |
04/16/2020 |
Unicel DxH 800 Coulter Cellular Analysis System |
Beckman Coulter |
Samy Puccio |
| K192735 |
04/03/2020 |
Diode Laser Hair Removal Machine |
Beijing Lead Beauty S & T Co., Ltd |
Jiao Zhang |
| K191970 |
04/06/2020 |
Diode Laser Hair Removal System |
Beijing Sano Laser S&T Development Co., Ltd |
Hongbo Zhang |
| K193464 |
04/13/2020 |
ND:YAG Laser |
Beijing Superlaser Technology Co., Ltd. |
Shi Shuang |
| DEN180055 |
04/29/2020 |
CARPEDIEM System |
Bellco srl (now part of Medtronic, Inc) |
Matteo Chiappini |
| K200533 |
04/27/2020 |
binx io CT/NG Assay and binx io CT/NG System |
binx health Inc |
Sarah Kalil |
| K190139 |
04/24/2020 |
Zircos-Com |
Bioden Co., Ltd |
Kim Hye Min |
| K200868 |
04/17/2020 |
SI-Restore Sacroiliac Joint Fixation System |
Biofusion Medical |
Rylan Reed |
| K200590 |
04/28/2020 |
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 ╡g/mL) |
bioMerieux, Inc |
Cherece L. Jones |
| K193373 |
04/15/2020 |
Comprehensive« Reverse Shoulder |
Biomet Inc. |
Kari Hovorka |
| K200444 |
04/23/2020 |
Biomonitor III, Biomonitor IIIm |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K192246 |
04/30/2020 |
Biowy PICC Catheter S Kit |
Biowy Corporation |
Arthur Lu |
| K192958 |
04/02/2020 |
TwitchView System |
Blink Device Company |
Justin Hulvershorn |
| K200787 |
04/23/2020 |
BSD3543W |
Bontech Co. Ltd |
Ki Chan Ahn |
| K200733 |
04/17/2020 |
Opticross 35 15 MHz Peripheral Imaging Catheter |
Boston Scientific Corporation |
Jennifer L. Foley |
| K200257 |
04/17/2020 |
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System |
Boston Scientific Corporation |
Catherine Sanford |
| K193591 |
04/02/2020 |
ARC 400 |
BOWA-electronics GmbH & Co. KG |
Wolf-Ruediger Fritz |
| K192145 |
04/21/2020 |
Galileo Vertebral Body Replacement Device |
Bright Spine |
Robert Simonson |
| K200600 |
04/20/2020 |
Sentinel |
C-Rad Positioning AB |
Thomas Matzen |
| K193181 |
04/15/2020 |
Serranator PTA Serration Balloon Catheter |
Cagent Vascular, LLC |
Carol Burns |
| K193153 |
04/24/2020 |
SPIRA-C Integrated Fixation System |
Camber Spine Technologies |
Daniel Pontecorvo |
| K200887 |
04/15/2020 |
AS-10 |
Canon, Inc. |
Akira Hirai |
| K200755 |
04/16/2020 |
Caption Guidance |
Caption Health |
Sam Surette |
| K200519 |
04/30/2020 |
CarboClear« II Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K200208 |
04/27/2020 |
Agape Warming Personal Lubricant |
CC Wellness LLC |
Marlent Perez |
| K200688 |
04/09/2020 |
hyperion X5, NewTom GO, X-RADiUS COMPACT |
CEFLA S.C. |
Lorenzo Bortolotti |
| K192552 |
04/17/2020 |
Irradiation Cosmetic Device |
Chongqing Peninsula Medical Technology Co., Ltd. |
Zhang Sudi |
| K200576 |
04/06/2020 |
ClearMask Transparent Surgical Face Mask |
ClearMask, LLC |
Aaron Hsu |
| K200181 |
04/15/2020 |
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Ng Kok Howe |
| K200238 |
04/26/2020 |
ControlRad Sterile Cover |
ControlRad, Inc |
Chris Fair |
| K200863 |
04/28/2020 |
Tiger« Occipital-Cervical-Thoracic Spinal Fixation System |
CoreLink, LLC |
Steve Mounts |
| K200705 |
04/23/2020 |
Nurochek System |
Cryptych Pty Ltd |
Angela Roche |
| K192228 |
04/01/2020 |
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant |
CS Medical L.L.C. |
Kendall Ashe |
| K192167 |
04/13/2020 |
CuraRad-ICH |
CuraCloud Corp. |
Xiaoxiao Liu |
| K200552 |
04/02/2020 |
EVOS Lumbar Interbody System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K200053 |
04/21/2020 |
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) |
DANNIK |
Olga Haberlad |
| K193588 |
04/16/2020 |
DD Contrast |
Dental Direkt GmbH |
Uwe Greitens |
| K200099 |
04/13/2020 |
s-Clean SQ-SL Implant System Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K193549 |
04/16/2020 |
SIGMA High Performance (HP) Partial Knee System |
DePuy Ireland UC |
Erin Combs |
| K193027 |
04/02/2020 |
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K200319 |
04/02/2020 |
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K200101 |
04/27/2020 |
WOLF Thrombectomy V System |
DeVoro Medical, Inc. |
Michael P. Wallace |
| K200752 |
04/22/2020 |
DB-Orthopedics |
Dimensional Bioceramics, LLC |
Duran N. Yetkinler |
| K182400 |
04/14/2020 |
Solax Powered Wheelchair (Models: S7101, S7103) |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K192408 |
04/24/2020 |
Custodiol HTK Solution |
Dr. Franz Kohler Chemie GmbH |
Clifton Czarnojon |
| K200188 |
04/01/2020 |
DSI Dental Implant System |
DSI Dental Solutions Ltd |
Shlomi Krasner |
| K192514 |
04/02/2020 |
Patient Monitor |
Edan Instruments, Inc. |
Alice Yang |
| K200776 |
04/06/2020 |
Eko CORE |
Eko Devices, Inc. |
Arezou Azar |
| K200523 |
04/30/2020 |
Biolign« Roto-Loc Cervical Plate System |
Elite Surgical Supplies (PTY) LTD |
Thanos Spirakis |
| K200624 |
04/27/2020 |
Percutaneous Introducer |
Epimed International Inc. |
Preston Frasier |
| K200044 |
04/10/2020 |
SkinStylus SteriLock MicroSystem |
Esthetic Education LLC |
Marc C. Sanchez |
| K192097 |
04/29/2020 |
Exactech« Equinoxe« Stemless Humeral Components |
Exactech, Inc. |
Zach Sharrah |
| K191997 |
04/22/2020 |
FAICO CMF System |
FAICO Medical LLC |
Heman Dario Fernandez |
| K192015 |
04/03/2020 |
Faico Dental Implant System |
FAICO Medical LLC |
Hernan Dario Fernandez |
| K192017 |
04/24/2020 |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K200668 |
04/10/2020 |
DR-ID 1200SDK System |
FUJIFILM Corporation |
Randy Vader |
| K193394 |
04/29/2020 |
Humeral Cup Stability & Humeral Cup 135/145o Stability |
FX Shoulder USA, Inc. |
Kathy Trier |
| K200388 |
04/14/2020 |
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector |
GA Health Company Limited |
Cindy Ye |
| K193282 |
04/10/2020 |
SIGNA Premier |
GE Healthcare (GE Medical Systems, LLC) |
Glen Sabin |
| K200158 |
04/17/2020 |
LOGIQ E10 |
GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC |
Tracey Ortiz |
| K200119 |
04/01/2020 |
LOGIQ E10s |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K192679 |
04/10/2020 |
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use |
Gemtier Medical (Shanghai) Inc. |
Lenny Cao |
| K192609 |
04/21/2020 |
Globalcare Blood Pressure Monitor |
Globalcare Medical Technology Co., Ltd |
Janice Deng |
| K200025 |
04/06/2020 |
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K200023 |
04/06/2020 |
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K193033 |
04/24/2020 |
GSI Audera Pro |
Grason Stadler |
Brent Nissly |
| K191992 |
04/29/2020 |
PELNAC Bilayer Wound Matrix |
Gunze Limited |
Hidenori Nishioka |
| K192644 |
04/23/2020 |
GM501 SpermAir and GM501 SpermActive |
Hamilton Thorne Incorporated |
Donald Fournier |
| K200581 |
04/25/2020 |
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) |
Hartalega NGC SDN. BHD. |
Kuan Mun Leong |
| K200019 |
04/06/2020 |
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) |
Hartalega NGC Sdn. Bhd. |
Kuan Mun Leong |
| K200541 |
04/28/2020 |
HiveÖ Stand-alone Anterior Lumbar Interbody System |
HD LifeSciences LLC |
John Sullivan |
| K192500 |
04/06/2020 |
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer |
Honsun(Nantong)Co.,Ltd |
Iris Du |
| K192082 |
04/21/2020 |
Droplet Pen Needle 34G |
HTL-Strefa S.A |
Aleksandra Prazmowska-Wilanowska |
| K200729 |
04/16/2020 |
HydroCision SpineJet System |
HydroCision, Inc. |
Mark J Lewis |
| K192154 |
04/20/2020 |
Rio Vial-to-Bag Drug Reconstitution Device |
ICU Medical |
Sheila Antonio |
| K200762 |
04/23/2020 |
CoLink Cfx Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K193369 |
04/14/2020 |
Xelis Dental 2.0 |
Infinitt Healthcare Co.,Ltd. |
Sang Wook Cho |
| K192197 |
04/28/2020 |
Magicore II System |
InnoBioSurg Co., Ltd. |
Eun-Ji Yoo |
| K193218 |
04/07/2020 |
Innovision Audio |
Innovere Medical Inc. |
Lynsie Thomason |
| K200564 |
04/03/2020 |
Aria System |
Inova Labs |
Reuben Lawson |
| K200744 |
04/21/2020 |
Instylla Microcatheter |
Instylla, Inc. |
Jennifer Greer |
| K192176 |
04/02/2020 |
IntelePACS |
Intelerad Medical Systems Incorporated |
Luce Caron |
| K192803 |
04/29/2020 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical |
Crystal Ong |
| K200622 |
04/01/2020 |
Focus 43C detector, TRIMAX 43C detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K200807 |
04/29/2020 |
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit |
IRRAS USA Inc. |
Niloufa Insanally |
| K192658 |
04/01/2020 |
Manual Wheelchair |
Jerry Medical Instrument (Shanghai) Co., Ltd. |
Jianguo Chen |
| K193592 |
04/28/2020 |
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K192068 |
04/25/2020 |
i-ED COIL |
Kaneka Pharma America LLC |
Kazuhiko Inoue |
| K193213 |
04/28/2020 |
Vicks VNT200 No Touch Forehead Thermometer |
Kaz USA, Inc., a Helen of Troy Company |
Matt J. Baun |
| K193250 |
04/06/2020 |
Irrigation Tubing with CO2 or Air |
KeyMed (Medical and Industrial Equipment) Ltd. |
Andy Hollingsworth |
| K200072 |
04/10/2020 |
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid |
Kimberly-Clark Corporation |
Juan Marquez |
| K200709 |
04/17/2020 |
Kyocera Bipolar Hip System |
Kyocera Medical Technologies, Inc. |
Anthony DeBenedictis |
| K200141 |
04/27/2020 |
Oxi-W System |
LD Technology LLC |
Albert MAAREK |
| K193350 |
04/27/2020 |
Leadtek Fingertip Pulse Oximeter |
Leadtek Research Inc. |
K. S. Lu |
| K191762 |
04/01/2020 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
Alberto Rodrigues-Navarro |
| K200070 |
04/23/2020 |
ARx Spinal System |
Life Spine Inc. |
Angela Batker |
| K200338 |
04/17/2020 |
ProLift Lateral Fixated |
Life Spine Inc. |
Angela Batker |
| K200896 |
04/28/2020 |
Solstice CCI |
Life Spine Inc. |
Angela Batker |
| K200308 |
04/06/2020 |
MTS Lefamulin 0.016- 256 ╡g/mL |
Liofilchem s. r. 1. |
Fabio Brocco |
| K200022 |
04/03/2020 |
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System |
LiverMoreTech Inc. |
Jae Hong Kim |
| K192856 |
04/24/2020 |
MT One |
M&T SRL |
Fiorenzo Rossi |
| K200010 |
04/02/2020 |
FilmArray BCID2 Control Panel M416 |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K191930 |
04/15/2020 |
7 mm Extended Length Endoscope |
Maquet Cardiovascular, LLC |
Mark Dinger |
| K200670 |
04/16/2020 |
EON Portable RO Water Purification System |
Mar Cor Purification, Inc. |
Mark Arnold |
| K191882 |
04/22/2020 |
Masimo Centroid System |
Masimo Corporation |
Linus Park |
| K191935 |
04/09/2020 |
Nautilus Smart ECMO Module |
MC3 Incorporated |
Adam Viitala |
| K191720 |
04/17/2020 |
BRUIS Software Suite |
Mechanodontics, Inc. |
Mehdi Roein-Peikar |
| K192834 |
04/26/2020 |
MECTA Sigma |
Mecta Corporation |
Robin Nicol |
| K191816 |
04/29/2020 |
M-Vizion Femoral Revision System Extension |
Medacta International SA |
Stefano Baj |
| K200122 |
04/20/2020 |
MOTO PFJ System |
Medacta International SA |
Stefano Baj |
| K192099 |
04/02/2020 |
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System |
Medax Srl Unipersonale |
Stefano Cavalieri |
| K192101 |
04/02/2020 |
Medone Ultra, Medextra |
Medax Srl Unipersonale |
Stefano Cavalieri |
| K200902 |
04/30/2020 |
ClickClean |
Medeon Biodesign, Inc. |
Tsung-Yu Hsieh |
| K192807 |
04/23/2020 |
Duo-Flow Side x Side Double Lumen Catheter |
Medical Components Inc. (dba MedComp) |
Courtney Nix |
| K193104 |
04/09/2020 |
Unified Arrhythmia Diagnostic System PocketECG IV |
Medicalgorithmics S.A. |
Marek Dziubinski |
| K192230 |
04/23/2020 |
MF SAFECATH |
MediFirst Co., Ltd. |
Ha Tae Joo |
| K192988 |
04/01/2020 |
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use |
Medline Industries, Inc. |
Jennifer Mason |
| K193217 |
04/06/2020 |
SensiCare PI and SensiCare PI Micro Surgical Gloves |
Medline Industries, Inc. |
Jennifer Mason |
| K192646 |
04/02/2020 |
SYMPHONYÖ OCT System |
Medos International SARL |
Sheree Geller |
| K200245 |
04/24/2020 |
EXPEDIUM« Spine System; EXPEDIUM VERSE« Spine System |
Medos International Sαrl |
Rhoda Maddonni |
| K193305 |
04/23/2020 |
DynaClip Bone Staple |
MedShape, Inc. |
Jack Griffis |
| K200074 |
04/24/2020 |
O-arm O2 Imaging System |
Medtronic Inc. |
Dean Honkonen |
| K200630 |
04/09/2020 |
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags |
Medtronic, Inc. |
Jen Correa |
| K192636 |
04/08/2020 |
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) |
Medtronic, Inc. |
Nancy Cameron |
| K193571 |
04/08/2020 |
Go2Wire Guide Wire |
Merit Medical System, Inc. |
Mark Mullaney |
| K200847 |
04/23/2020 |
Surgical Face Mask |
Mexpo International Inc. |
Tim Thai |
| K200007 |
04/25/2020 |
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar |
MicroPort Orthopedics Inc. |
Allen Mamaril |
| K200547 |
04/16/2020 |
Traxcess 14 SELECT Guidewire |
MicroVention Inc. |
Ganesh Balachandar |
| K191867 |
04/09/2020 |
ATLAS Plating System |
MiRus, LLC |
Jordan Bauman |
| K192558 |
04/06/2020 |
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter |
MIVI Neurovascular |
Janel Hurtado |
| K200500 |
04/15/2020 |
Molekule Air Pro RX |
Molekule, Inc. |
Frank Bianco |
| K193573 |
04/10/2020 |
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro |
Molnlycke Health Care US LLC. |
Calen Souther |
| K192781 |
04/14/2020 |
UroLift System Procedure Kit Sterilization Tray |
NeoTract, Inc. |
Brian Gall |
| K191492 |
04/24/2020 |
Maxxi Position Sensor |
Neurovirtual USA, INC. |
Eduardo Faria |
| K193351 |
04/21/2020 |
NinesAI |
Nines, Inc. |
Russell Stewart |
| K193322 |
04/02/2020 |
NovaCross CTO Microcatheter |
Nitiloop Ltd. |
Amir Pansky |
| K200403 |
04/14/2020 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K200204 |
04/06/2020 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Rachel Gilbert |
| K200867 |
04/28/2020 |
Implantswiss Dental Implant System and Implantswiss Dental Abutment System |
Novodent SA |
Cem Kocer |
| K193074 |
04/21/2020 |
Bevel Up Holder |
NSP Tech Pte Ltd |
HC TAN |
| K200397 |
04/24/2020 |
Single Use Biopsy Forceps FB-456D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K192498 |
04/28/2020 |
Single Use Injector |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K193026 |
04/03/2020 |
Visera Elite II Video System Center, Visera Elite II Endoeye 3D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K191084 |
04/07/2020 |
The Optimotion Blue Total Knee System |
Optimotion Implants, LLC |
Dan Justin |
| K200254 |
04/27/2020 |
Mydriatic Hyperspectral Retinal Camera (MHRC-C1) |
Optina Diagnostics |
Jean-Philippe Sylvestre |
| K200282 |
04/08/2020 |
Orfit Aerial Couchtop |
Orfit Industries NV |
Eddy Marivoet |
| K200594 |
04/27/2020 |
Capnostream 35 Portable Respiratory Monitor |
Oridion Medical 1987 Ltd. |
Lital David |
| K200642 |
04/10/2020 |
OrthAlign Plus System |
OrthAlign, Inc. |
Karyl Haskell |
| K200052 |
04/09/2020 |
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K200696 |
04/02/2020 |
FIREBIRD SI Fusion System |
Orthofix Inc. |
Jacki Koch |
| K193494 |
04/06/2020 |
OriginÖ Anterior Cervical Plate System |
Orthopaedic & Spine Development |
Nicolas Palillon |
| K192701 |
04/21/2020 |
DIBS (Digital Indirect Bonding System) |
OrthoSelect, LLC |
Steven N. Gardner |
| K200665 |
04/12/2020 |
VERASENSE for Stryker Triathlon |
OrthoSensor, Inc. |
Deborah Escobar Johnson |
| K193580 |
04/01/2020 |
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR |
OrthoSensor, Inc. |
Deborah Johnson |
| K192108 |
04/08/2020 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
Martine Fortin |
| K192034 |
04/21/2020 |
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc |
Pathway, LLC |
David Stroup |
| K200559 |
04/20/2020 |
CarpX |
PAVmed, Inc. |
Lishan Aklog |
| K200771 |
04/22/2020 |
Indigo Aspiration System Lightning Aspiration Tubing |
Penumbra, Inc. |
Micaela Victoria |
| K192063 |
04/24/2020 |
PGDx elio tissue complete |
Personal Genome Diagnostics |
Jennifer Dickey |
| K192875 |
04/16/2020 |
Philips Biosensor BX100 |
Philips Medical Systems |
Suzanne Goodman |
| K200713 |
04/09/2020 |
EchoNavigator |
Philips Medical Systems Nederland B.V. |
Ioana Ulea |
| K193215 |
04/10/2020 |
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland BV |
Jan Van de Kerkhof |
| K193329 |
04/09/2020 |
PreXion3D Explorer EX |
PreXion Corporation |
Hiroaki Takahashi |
| K193161 |
04/21/2020 |
Pristine Scope |
Pristine Surgical |
Stewart B. Davis |
| K192183 |
04/23/2020 |
RocaTub Ureteral Catheter |
Promepal Sam |
Mohamed Rekik |
| K193459 |
04/27/2020 |
Panther Stereotactic |
Prowess Inc. |
Rachel Scarano |
| K192517 |
04/22/2020 |
Psychemedics Microplate EIA for Cotinine in Hair |
Psychemedics Corporation |
Virginia Hill |
| K192169 |
04/30/2020 |
PulsioFlex Monitoring System with ProAQT Sensor |
Pulsion Medical Systems SE |
Tobias Klaempfl |
| K200168 |
04/22/2020 |
Dermapose Access |
Puregraft LLC |
Olivia Kim |
| K193363 |
04/14/2020 |
Dermapose Refresh |
Puregraft LLC |
Olivia Kim |
| K200477 |
04/08/2020 |
Flex Body Speeder |
Quality Electrodynamics, LLC |
Eric Yeh |
| K192850 |
04/13/2020 |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
Qura S.r.l. |
Raffaella Tommasini |
| K193640 |
04/09/2020 |
ClearCalc |
Radformation, Inc. |
Kurt Sysock |
| K193300 |
04/08/2020 |
AIMI-Triage CXR PTX |
RADLogics, Inc. |
Moshe Becker |
| K200726 |
04/13/2020 |
AcuityPDR |
Radmedix LLC |
Gabriel Issa |
| K193032 |
04/20/2020 |
KY Grosz Liquid |
RB Health (US) LLC |
Elizabeth Viguerie |
| K192982 |
04/14/2020 |
KY Grosz UltraGel |
RB Health (US) LLC |
Elizabeth Viguerie |
| K192138 |
04/09/2020 |
Rejuvapen NXT |
Refine USA LLC |
Brian Smith |
| K193388 |
04/27/2020 |
GlassLok Kits, GlassLok Powder, GlassLok Liquid |
Reliance Orthodontic Products Inc. |
Paula Wendland |
| K190353 |
04/10/2020 |
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac |
Residential Home Sleep Services |
Chris Gillette |
| K200326 |
04/09/2020 |
Powder Free Nitrile Examination Glove (Aqua Green) |
Riverstone Resources SDN BHD |
Suresh Kumar |
| K200121 |
04/18/2020 |
Route 92 Medical 088 Access System, 110 cm |
Route 92 Medical Inc. |
Kathy Tansey |
| K191574 |
04/09/2020 |
OxSAT 100 |
S.L.P. Ltd. |
Avi Yosef |
| DEN190028 |
04/16/2020 |
MyCare Psychiatry Clozapine Assay Kit |
Saladax Biomedical Inc |
Sue Werner |
| K200339 |
04/07/2020 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
Scully Kim |
| K193636 |
04/24/2020 |
SeaSpine Reef TH System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K200638 |
04/03/2020 |
LAP-iX Suction Irrigation |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K192719 |
04/03/2020 |
Osom Ultra Plus Flu A&B Test Kit |
Sekisui Diagnostics, LLC |
Nisha Li |
| K192445 |
04/02/2020 |
QwikCheck Chemical Indicators |
Serim Research Corporation |
Jackie Nelson |
| K200118 |
04/17/2020 |
Diode Laser Therapy Device |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K200024 |
04/20/2020 |
uMR 570 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin GAO |
| K200001 |
04/09/2020 |
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Shi Jufang |
| K200251 |
04/02/2020 |
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Shi Jufang |
| K200411 |
04/08/2020 |
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
Shi Jufang |
| K193275 |
04/11/2020 |
Nerve and Muscle Stimulator |
Shenzhen XFT Medical Limited |
Cindy Peng |
| K200199 |
04/06/2020 |
ADVIA Centaur CA 125II |
Siemens Healthcare Diagnostics, Inc. |
Fatima Pacheco |
| K200215 |
04/13/2020 |
ADVIA Centaur CEA Assay |
Siemens Healthcare Disgnostics Inc. |
Mey Lyn Vasquez |
| K200644 |
04/10/2020 |
ACUSON Freestyle Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Shruti Arora |
| K200707 |
04/15/2020 |
ACUSON Sequoia Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Sulgue Choi |
| K193326 |
04/16/2020 |
ARTIS Icono |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K200524 |
04/01/2020 |
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K200585 |
04/22/2020 |
Acuson SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions, USA, Inc. |
Christine Dunbar |
| K192013 |
04/07/2020 |
VERTICALE« Cervical System |
Silony Medical GmbH |
Melanie Lubjuhn |
| K192588 |
04/15/2020 |
G-EYE System |
SMART Medical Systems Ltd. |
Adva Yoselzon |
| K200826 |
04/24/2020 |
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks |
Smith&Nephew, Inc. |
Brad Sheals |
| K192475 |
04/23/2020 |
NemoFAB |
Software Nemotec S.L. |
Carlos Arias |
| K191422 |
04/06/2020 |
Neural Navigator |
Soterix Medical, Inc. |
Abhishek Datta |
| K192838 |
04/13/2020 |
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure |
Spectrum Medical Ltd |
Colleen Powell |
| K200312 |
04/06/2020 |
Tryptik Ti |
Spineart |
Frank Pennesi |
| K200816 |
04/30/2020 |
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices |
SpineEX, Inc. |
Andrew Rogers |
| K200539 |
04/09/2020 |
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl |
Sri Trang Gloves (Thailand) Public Company Limited |
Jarinya Jirojkul |
| K191885 |
04/08/2020 |
Standard Bougie |
Standard Bariatrics |
Alison Sathe |
| K200517 |
04/09/2020 |
Standard Trocar |
Standard Bariatrics |
Alison Sathe |
| K192382 |
04/20/2020 |
CapKlenZ |
Star Mountain Medical, Inc. |
Aaron Chiu |
| K200577 |
04/03/2020 |
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector |
STERIS Corporation |
Jennifer Nalepka |
| K192401 |
04/06/2020 |
Straumann Screw-Retained Abutments |
Straumann USA, LLC |
Jennifer M Jackson |
| K200613 |
04/15/2020 |
Tritanium« X TL Expandable Curved Posterior Lumbar Cage |
Stryker Corporation |
Jamie Wilson |
| K200666 |
04/23/2020 |
Stryker Xia 3 Power Adaptor |
Stryker Spine |
Megan Callanan |
| K191995 |
04/18/2020 |
S4 Screw System |
Subchondral Solutions, Inc. |
Sheryl McCoy |
| K200327 |
04/29/2020 |
Evry |
Synaptive Medical Inc. |
Maham Ansari |
| K200632 |
04/08/2020 |
TCAT TKA Instrument Tray Set |
THINK Surgical, Inc. |
George J. Prendergast |
| K191803 |
04/14/2020 |
Orthopedic Fixation Pin |
Tinavi (Anhui) Medical Technologies Co., Ltd. |
Jianhua Jiang |
| K200625 |
04/15/2020 |
I-View Gold and Imagen Gold Dental Sensors |
Trident s.r.l |
Giorgio Rizzo |
| K193390 |
04/02/2020 |
CS Model+ |
Trophy |
Marie-Pierre Labat-Camy |
| K200240 |
04/30/2020 |
Turbett Instrument Pod |
Turbett Surgical Inc. |
Rob Turbett |
| K200745 |
04/21/2020 |
Lariat, Hot/Cold Snare |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K191308 |
04/23/2020 |
U-Aligner |
Universal Orthodontic Laboratory Inc |
Jiahe Li |
| K193349 |
04/14/2020 |
Vapocoolshot Mist |
Vapocoolshot, Inc. |
Jacob Leibovici |
| K200608 |
04/03/2020 |
Eclipse Treatment Planning System v16.0 |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K191065 |
04/01/2020 |
Venus VivaTM |
Venus Concept USA Inc. |
Yoni Iger |
| K200185 |
04/22/2020 |
SYLFIRM X |
Viol Co., Ltd. |
Chai Kyoung Woo |
| K200703 |
04/14/2020 |
JiveX |
Visus Health IT GmbH |
Axel Schreiber |
| K193343 |
04/20/2020 |
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) |
VitalConnect, Inc. |
Cynthia Merrell |
| K193197 |
04/20/2020 |
QuickClear Mechanical Thrombectomy System |
Volcano AtheroMed Inc. |
Anna Gloria Stephen |
| K193561 |
04/15/2020 |
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch |
Weihai Xingtai Packaging Products Co.,Ltd. |
Miao Qifen |
| K193654 |
04/07/2020 |
BlueStar Rx |
WellDoc, Inc |
Sabyasachi Roy |
| K192350 |
04/30/2020 |
Medical Non-Ablative Fractional Laser Systems |
Wingderm Electro-Optics Ltd. |
Zhou Juan |
| K200162 |
04/21/2020 |
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) |
Wuhan Greentek Pty Ltd. |
Yarong Liu |
| K190984 |
04/22/2020 |
Infrared Forehead Thermometer |
Xiamen Ants Bro Technology Co., Ltd. |
Jane Xu |
| K192358 |
04/23/2020 |
Pressure Therapy System PT1003 |
Xiamen Senyang Co., Ltd. |
Nina Cai |
| K192290 |
04/30/2020 |
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown |
Xuchang Zhengde Environstar Medical Products Co., Ltd |
Johnny Johnny |
| K200167 |
04/23/2020 |
QuikClot Control+ |
Z-Medica, LLC |
Soraya King |
| K200814 |
04/28/2020 |
Affixus(R) Natural Nail(R) System Humeral Nail |
Zimmer GmbH |
Annemie Rehor Kausch |
| K200112 |
04/10/2020 |
Zimmer Hip Joint Replacement |
Zimmer GmbH |
Thomas Lincoln |
