| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K191774 |
09/30/2019 |
SmileAlign Orthodontic Aligner System |
3D Global Biotech Inc. |
Keng-Liang Ou |
| K192119 |
09/05/2019 |
3M Clarity Aligners |
3M Company |
Yanine Garcia-Quezada |
| K191355 |
09/11/2019 |
3MÖ High Fluid-Resistant Surgical Mask and 3MÖ High Fluid-Resistant Procedure Mask |
3M Health Care |
Angie Draper |
| K191595 |
09/13/2019 |
ARCHITECT STAT High Sensitivity Troponin-I |
Abbott Laboratories Diagnostics Division |
Judi Wallach |
| K192037 |
09/17/2019 |
Advisor VL Circular Mapping Catheter, Sensor Enabled |
Abbott Medical |
Tamara L. Stanczak |
| K190473 |
09/13/2019 |
ACIST RXi System and Navvus II Catheter |
ACIST Medical Systems, Inc. |
Sherri Mellingen |
| K191392 |
09/06/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
Karla Schaffner |
| K192106 |
09/03/2019 |
AcQRef Introducer Sheath |
Acutus Medical, Inc. |
Serena Sanginthirath |
| K190844 |
09/04/2019 |
Akesis Galaxy |
Akesis Inc |
Christopher Brown |
| K192102 |
09/25/2019 |
Thermoplastic Masks |
Aktina Medical Corporation |
Tony Spaccarotella |
| K190308 |
09/17/2019 |
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 Pedia |
AMD Medicom, Inc. |
Ronald Reuben |
| K192088 |
09/04/2019 |
GOLNIT Non-aborbable PTFE Surgical Suture |
Antarma LLC dba Golnit Sutures |
Armine Badalyan |
| K191294 |
09/06/2019 |
Transvaginal Access Platform |
Applied Medical Resources Corp. |
Corinne Yestrepsky |
| K190288 |
09/13/2019 |
Arthrex Tenodesis Button |
Arthrex Inc. |
Ivette Galmez |
| K183662 |
09/12/2019 |
Saline Wound Wash, SteriCleanse(TM) |
Ascent Consumer Products, Inc. |
Matthew Kornberg |
| K191537 |
09/26/2019 |
eCarbon IBDs |
Back 2 Basics Direct, LLC |
Scot Miller |
| K191845 |
09/06/2019 |
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) |
Barco NV |
Julie Vandecandelaere |
| K190499 |
09/06/2019 |
Gem FlowCoupler System |
Baxter/ Synovis Micro Companies Alliance Inc. |
Julie Carlston |
| K182886 |
09/06/2019 |
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer |
Beckman Coulter |
Samy Puccio |
| K183190 |
09/25/2019 |
NuStat |
Beeken Biomedical, LLC |
Richard A. Kendall |
| K190484 |
09/10/2019 |
BH Medical Dental Barrier Sleeves and Barrier Film |
BH Medical Products Co., Ltd. |
Xiaohua TAO |
| K192050 |
09/27/2019 |
ETEST Eravacycline (ERV) (0.002 û 32 ╡g/mL) |
bioMerieux SA |
Marine Taravant |
| K191459 |
09/13/2019 |
JuggerStitch Meniscal Repair Device |
Biomet Inc. |
Kyle Ponce |
| K191587 |
09/12/2019 |
L360 Thigh System |
Bioness Inc. |
Mercedes Bayani |
| K190250 |
09/06/2019 |
Microscope Navigation |
Brainlab AG |
Alexander Schwiersch |
| K190815 |
09/11/2019 |
BrainScope TBI |
BrainScope Company, Inc. |
Michael Singer |
| K191006 |
09/24/2019 |
EasiSlush |
Bridge to Life Ltd. |
Tom Keller |
| K191004 |
09/05/2019 |
Advocate Non-Contact Infrared Thermometer |
BroadMaster Biotech, Corp. |
Jen Ke-Min |
| K191718 |
09/24/2019 |
Buhlmann fCAL turbo and CALEX Cap |
BUHLMANN Laboratories AG |
Laura Zurbrugg |
| K191232 |
09/18/2019 |
AccuCath Ace Intravascular Catheter |
C.R. Bard, Inc |
Mona Shahrebani |
| K190483 |
09/23/2019 |
SPIRA Open Matrix ALIF and LLIF |
Camber Spine Technologies |
Erin Kriebel |
| K191685 |
09/16/2019 |
PicoWay Laser System |
Candela Corporation |
Brenda Geary |
| K191663 |
09/18/2019 |
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K192188 |
09/06/2019 |
Aquilion ONE (TSX-306A/3) V10.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K181602 |
09/10/2019 |
Pioneer Elite Diode Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K181601 |
09/09/2019 |
Precise SHP Diode Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K181614 |
09/10/2019 |
Sterling Supreme Diode Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K192012 |
09/12/2019 |
Capillus 112, Capillus 244 |
Capillus |
Patricia Schnoor |
| K192199 |
09/12/2019 |
CRC PC Smart Chamber K1 |
Capintec, Inc. |
Mary Anne Yusko |
| K190526 |
09/19/2019 |
High V+ Bone Cement, CarboClear« Fenestrated Pedicle Screws |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K192156 |
09/04/2019 |
Cartiva SCI instrumentation set |
Cartiva, Inc. |
Shriya Kafle |
| K191811 |
09/11/2019 |
Catalyst OrthoScience CSR Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K183444 |
09/09/2019 |
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector |
Cenorin, LLC |
Jenette A. Bennett |
| K190076 |
09/27/2019 |
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems |
Cepheid |
Yi-Ping Lin |
| K191301 |
09/11/2019 |
Ceribell Pocket EEG Device |
Ceribell, Inc. |
Josef Parvizi |
| K190029 |
09/26/2019 |
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar |
Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. |
Boping Ma |
| K191324 |
09/20/2019 |
CivaDerm |
CivaTech Oncology Inc. |
Suzanne Babcock |
| K192129 |
09/27/2019 |
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 |
John Christopher Phelan |
| K181428 |
09/20/2019 |
Clyra Wound Irrigation Solution |
Clyra Medical Technologies Inc. |
Steven V. Harrison |
| K183521 |
09/11/2019 |
CNAP Monitor |
CNSystems Medizintechnik GmbH |
Bernd Wellisch |
| K183586 |
09/13/2019 |
CapMedic |
Cognita Labs, LLC |
Rajoshi Biswas |
| K191070 |
09/04/2019 |
Signia Small Diameter Reloads |
Covidien |
Frank Gianelli |
| K181416 |
09/17/2019 |
Sapphire Dorsal Comfort Fit |
Crane Dental Laboratory, Inc |
Sharlene Schultz |
| K192010 |
09/24/2019 |
SmoothSkin BARE+ |
CyDen Limited |
Adam Stephens |
| K190875 |
09/25/2019 |
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 Research Center (International) |
Linda Van Leeuwen |
| K190758 |
09/04/2019 |
Opus Bulk Fill APS, Opus Bulk Fill Flow APS |
DentsCare LTDA |
Roberta Uyara |
| K190059 |
09/27/2019 |
CEREC Guides |
Dentsply Sirona |
Karl J. Nittinger |
| K190323 |
09/25/2019 |
Aloe Glide Lubricant |
Desert Harvest, Inc |
Heather Florio |
| K182009 |
09/26/2019 |
Dia-Proseal |
Diadent Group International |
Myung Sub Kim |
| K183687 |
09/25/2019 |
LifeWindow LW8 Lite |
Digicare Biomedical Technology, Inc. |
Eduardo Miranda |
| K190048 |
09/30/2019 |
UF(II) Anatomic abutment |
DIO Corporation |
Jiae Park |
| K183103 |
09/18/2019 |
EMS Belt (Model MC0485) |
Dongguan Yingfeng Metal & Plastic Products Co., Ltd |
Zesheng Chen |
| K191187 |
09/18/2019 |
Dornier MINNOW Ureteral Catheter |
Dornier MedTech America Inc |
John Hoffer |
| K192364 |
09/26/2019 |
GXR-Series Diagnostic X-Ray System |
DRGEM Corporation |
Ki-Nam Yang |
| K180001 |
09/27/2019 |
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant |
Embla Systems |
Sanjay Mehta |
| K190856 |
09/20/2019 |
SeeFactorCT3 |
Epica International Inc. |
Daniel Naimey |
| K182631 |
09/19/2019 |
SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) |
Eurogreen International Inc. |
David Hsieh |
| K190403 |
09/06/2019 |
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 Corporation |
Jerry Lin |
| K191545 |
09/26/2019 |
Exogenesis Hernia Mesh |
Exogenesis Corporation |
Joseph Khoury |
| K191577 |
09/06/2019 |
Willow Wearable Breast Pump 2.0 |
Exploramed NC7, Inc. |
Steve Holmes |
| K191844 |
09/30/2019 |
Fidmi Low Profile Enteral Feeding Device |
Fidmi Medical Ltd |
Shahar Millis |
| K191113 |
09/18/2019 |
geko T-2 and geko T-3 Neuromuscular Stimulators |
Firstkind Limited |
Neil Buckley |
| K192421 |
09/27/2019 |
EpiFaith Syringe |
Flat Medical Co., Ltd |
Shao Wei Tseng |
| K192371 |
09/26/2019 |
BioZorb SP Marker |
Focal Therapeutics |
Dhaval Saraiya |
| K192368 |
09/27/2019 |
CATSmart |
Fresenius Kabi AG |
Shane Sawall |
| K191747 |
09/27/2019 |
FUJIFILM Duodenoscope Model ED-580XT |
FUJIFILM Corporation |
Randy Vader |
| K183433 |
09/05/2019 |
FUJIFILM Ultrasonic Endoscope |
Fujifilm Corporation |
Randy Vader |
| K192195 |
09/26/2019 |
Sterile Dilator |
Galt Medical Corp. |
David Derrick |
| K191112 |
09/19/2019 |
GEHC DXA Bone Densitometers with enCORE version 18 |
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
Martha Kamrow |
| K182722 |
09/27/2019 |
XLR8 Abdominal Wound Dressing Kit |
Genadyne Biotechnologies |
Swara Vashi |
| K191748 |
09/26/2019 |
Genesys Spine Sacroiliac Joint Fusion System |
Genesys Spine |
William W. Sowers |
| K183438 |
09/03/2019 |
Geomed Vascular Dilators |
Geomed Medizin-Technik GmbH & Co. |
Hanno Haug |
| K191243 |
09/17/2019 |
HEDRON Cervical Spacers |
Globus Medical Inc. |
Kelly Baker |
| K191391 |
09/18/2019 |
HEDRON Lumbar Spacers |
Globus Medical Inc. |
Kelly Baker |
| K191552 |
09/18/2019 |
GM501 Mineral Oil |
Hamilton Thorne Inc. |
Donald Fournier |
| K190383 |
09/05/2019 |
GM501 Wash |
Hamilton Thorne, Inc. |
Donald Fournier |
| K192326 |
09/19/2019 |
HardyDisk AST Lefamulin 20╡g (LMU20) |
Hardy Diagnostics |
Anna Klavins |
| K190454 |
09/26/2019 |
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. |
Kuan Kam Hon |
| K190507 |
09/16/2019 |
Full Automatic (NIBP) Blood Pressure Monitor |
Health & Life Co. ltd. |
J.S. Hsu |
| K190932 |
09/13/2019 |
RFID Localization System |
Health Beacons, Inc. |
Nancy Confrey |
| K192391 |
09/26/2019 |
Spectralis HRA+OCT and Variants |
Heidelberg Engineering GmbH |
Arianna Schoess Vargas |
| K190841 |
09/13/2019 |
SCENARIA View |
Hitachi Healthcare Americas |
Aaron Pierce |
| K191801 |
09/13/2019 |
PROBEAT-CR |
Hitachi Ltd. |
Tomoyuki Seino |
| K183574 |
09/06/2019 |
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes |
Huntleigh Healthcare Ltd |
Steve Monks |
| K191034 |
09/04/2019 |
VPS Impression Material |
Hygedent Inc. |
Peng Wang |
| K182355 |
09/06/2019 |
Secret RF Smartcure Applicator with electrodes |
Ilooda Co., Ltd. |
Yun-Jung Ha |
| K191530 |
09/26/2019 |
StoneChecker |
Imaging Biometrics, LLC |
Timothy Dondlinger |
| K183364 |
09/13/2019 |
Bellavista |
Imtmedical AG |
Beat Keller |
| K192332 |
09/20/2019 |
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
Eben Gordon |
| K191710 |
09/05/2019 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K191641 |
09/16/2019 |
AFFINITY û Variable Angle Distal Radius System, AFFINITY û Variable Angle Distal Radius Plates, AFFINITY û Variable Angle Distal Radius Screws |
Industrias Medicas Sampedro S.A.S |
Liliana Zuluaga-Idarraga |
| K192354 |
09/24/2019 |
Innovasis Gibralt Spine System |
Innovasis, Inc. |
Marshall McCarthy |
| K191679 |
09/20/2019 |
Omnipod DASH Insulin Management System with interoperable technology |
Insulet Corporation |
Julie Perkins |
| K180523 |
09/20/2019 |
INTAI Surgery Navigation System |
Intai Technology Corporation |
Shih-Chang Chuang |
| K192112 |
09/27/2019 |
FlexBand Plus |
International Life Sciences |
Tiffini Wittwer |
| K183695 |
09/12/2019 |
OrthoAnalysis Software |
Inteware Co., Ltd. |
Wayne Tsai |
| K191629 |
09/12/2019 |
faceLITE |
iSMART Marketing Svcs Ltd |
Susan D'Arcy |
| K183665 |
09/06/2019 |
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use |
Jiangsu Micsafe Medical Technology Co., Ltd. |
Tony Yang |
| K190213 |
09/06/2019 |
Yikang Endotracheal Tube |
Jiangxi Yikang Medical Instrument Group Co., Ltd |
Nicholas Su |
| K182671 |
09/21/2019 |
Medi-Direct TENS Pen |
JKH USA, LLC |
Bill Quanqin Dai |
| K191949 |
09/13/2019 |
UNFOLDER Vitan Inserter |
Johnson & Johnson Surgical Vision, Inc. |
Silvia Jiang-Hughes |
| K191357 |
09/18/2019 |
Flexible HD Cysto-Urethroscope System |
KARL STORZ Endoscopy-America, Inc. |
Irina Fedorov |
| K181986 |
09/06/2019 |
Klinly Ultrasonic Tongue Cleaner |
KEA Products Ltd |
Michael Schmidt |
| K191524 |
09/29/2019 |
Visalys Tooth Primer |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K190199 |
09/26/2019 |
SepaSperm Washing Solution, SepaSperm Solution |
Kitazato Corporation |
Futoshi Inoue |
| K191800 |
09/16/2019 |
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. |
Cho Sow Fong |
| K191945 |
09/10/2019 |
KOWA nonmyd 8 |
Kowa Company, Ltd. |
Nariaki Morita |
| K190708 |
09/16/2019 |
AccelFix Lumbar Interbody Fusion Cage System |
L&K Biomed Co., Ltd. |
Jihyeon Seo |
| K191121 |
09/06/2019 |
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, Apio |
Lentechs, LLC |
Robin Sears |
| K191927 |
09/20/2019 |
Hinged Laminoplasty System |
Life Spine, Inc. |
Angela Batker |
| K191908 |
09/04/2019 |
MTS Imipenem 0.016-256 ╡g/mL |
Liofilchem s.r.l. |
Fabio Brocco |
| K190899 |
09/05/2019 |
bili-hut |
Little Sparrows Technologies, Inc. |
Erica Konston |
| K191742 |
09/25/2019 |
ARIES MRSA Assay |
Luminex Corporation |
Kate Linak |
| K191998 |
09/24/2019 |
Mako Total Hip Application, Mako Total Knee Application |
MAKO Surgical Corp. |
Shikha Khandelwal |
| K191947 |
09/17/2019 |
VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord |
Maquet Cardiovascular, LLC. |
Mark Dinger |
| K192148 |
09/05/2019 |
Freedom Primary PCK |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K190022 |
09/25/2019 |
SafeBreath Filter Mouthpiece |
MD Diagnostics Limited |
Glen Hillsley |
| K191457 |
09/18/2019 |
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) |
MED-EL Elektromedizinische Geraete GmbH |
Ines Roman Santiago |
| K191300 |
09/12/2019 |
MectaLock Ti Suture Anchor |
Medacta International SA |
Stefano Baj |
| K192352 |
09/27/2019 |
MiniMAX |
Medacta International SA |
Stefano Baj |
| K191848 |
09/30/2019 |
APTUS Wrist Spanning Plates 2.5 |
Medartis AG |
Andrea Schweizer |
| K190536 |
09/25/2019 |
Mediracer NCS |
Mediracer Oy |
Lassi Laitinen |
| K191378 |
09/15/2019 |
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe |
Medline Industries, Inc. |
Stephanie Augsburg |
| K191212 |
09/24/2019 |
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, |
Medos International SARL |
Sergio M. Cordeiro |
| K183708 |
09/17/2019 |
Poly Clear |
Medtek Skincare, LLC |
Gary Richardson |
| K191148 |
09/12/2019 |
Medtronic HV-RÖ Bone Cement, KyphonÖ XpedeÖ Bone Cement, CD HorizonÖ Fenestrated Screw Set |
Medtronic Sofamor Danek, USA Inc. |
Shweta Sharma |
| K192296 |
09/20/2019 |
Medtronic 6F Taiga Guiding Catheter |
Medtronic Vascular |
Colleen Mullins |
| K190574 |
09/24/2019 |
Patient Assistant Model PA97000 |
Medtronic, Inc |
Cheryl Swanson |
| K191444 |
09/27/2019 |
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir |
Medtronic, Inc. |
Harsh Dharamshi |
| K192252 |
09/19/2019 |
ProPerformance Recovery System |
Menlo Brands LLC |
Sam Chi |
| K192276 |
09/20/2019 |
Merge Cardio |
Merge Healthcare Incorporated |
Lisa Baumhardt |
| K191435 |
09/06/2019 |
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 |
Nalu Medical, Inc. |
Michele Chin-Purcell |
| K191605 |
09/11/2019 |
Neocis Guidance System (NGS) |
Neocis Inc. |
Thomas E. Claiborne |
| K191599 |
09/13/2019 |
NICO Myriad NOVUS |
NICO Corporation |
Sean Spence |
| K182921 |
09/13/2019 |
Infinix Universal Composite |
Nobio Ltd. |
Inbal Beinglass Peled |
| K183391 |
09/24/2019 |
Novidia Universal Bond |
Nobio Ltd. |
Inbal Beinglass Peled |
| K191336 |
09/26/2019 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Aditya Sharma |
| K192435 |
09/26/2019 |
NuVasive NuvaLine |
NuVasive, Incorporated |
Manthan Damani |
| K191500 |
09/03/2019 |
NuVasive« ACP System |
NuVasive, Incorporated |
Jessica Silverman |
| K183525 |
09/06/2019 |
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183419 |
09/05/2019 |
EVIS EXERA III Bronchovideoscope Olympus BF-XT190 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183416 |
09/06/2019 |
Rhino-Laryngo Videoscope Olympus ENF-VT3 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K191765 |
09/25/2019 |
OMNI TiN Coated Apex KneeÖ System |
OMNI life science, Inc. |
Christina Rovaldi |
| K183215 |
09/07/2019 |
Focus TENS Therapy, Model PM710-M/-L |
Omron Healthcare, Inc. |
Renee Thornborough |
| K192344 |
09/19/2019 |
Sapphire NC Plus Coronary Dilatation Catheter |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K183347 |
09/04/2019 |
K3 |
Osstem Implant Co., Ltd. |
Hyeri Han |
| K191179 |
09/04/2019 |
Myo Plus |
Otto Bock Healthcare Products GmbH |
Rene Urtz |
| K191782 |
09/06/2019 |
TTC Phantom Intramedullary Nail System |
Paragon 28, Inc. |
Eric Lintula |
| K190930 |
09/05/2019 |
SmarTemp X1 |
Parkell, Inc. |
David Mott |
| K183516 |
09/06/2019 |
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
PENTAX of America, Inc. |
William Goeller |
| K183370 |
09/11/2019 |
PeraMobile and PeraWatch |
PeraHealth, Inc. |
Brad Coleman |
| K192259 |
09/20/2019 |
Philips IntelliSite Pathology Solution |
Philips Electronics Nederland B.V. |
Liselotte Kornmann |
| K192226 |
09/06/2019 |
Lumify Diagnostic Ultrasound System |
Philips Healthcare |
Paul Elias |
| K191503 |
09/04/2019 |
MobileRay Pulse SE Digital Imaging System |
Portavision Medical LLC |
Terry Ancar |
| K181606 |
09/27/2019 |
Precision Spine Navigation Instrumentation |
Precision Spine, Inc. |
Michael C. Dawson |
| K191853 |
09/05/2019 |
Dual-Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K191521 |
09/27/2019 |
Radiance 330 Proton Beam Therapy System |
ProTom International Holding Corporation |
Stephen L. Spotts |
| K190668 |
09/09/2019 |
Encompass 15 Channel Head Coil, 3T |
Qfix |
Alexandra Low Smythe |
| K192123 |
09/05/2019 |
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream |
Qingdao Hightop Biotech Co., Ltd. |
Allen Lee |
| K192254 |
09/18/2019 |
InnoSight Diagnostic Ultrasound System |
Qisda Corporation |
Johnson Sheu |
| K192160 |
09/06/2019 |
EVO Platform |
Quanta System, S.p.A |
Francesco Dell'Antonio |
| K191842 |
09/17/2019 |
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm |
Quanta System, S.p.A. |
Francesco DellÆAntonio |
| K191516 |
09/12/2019 |
Ali Interbody Fusion System |
Raed M. Ali, MD., Inc. |
Raed Ali |
| K190398 |
09/12/2019 |
Republic Spine Restore Intervertebral Body Fusion System |
Republic Spine LLC |
James Doulgeris |
| K191419 |
09/12/2019 |
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire |
Rex Medical, L.P. |
Colin Valentis |
| K181478 |
09/13/2019 |
Roosin Xeroform Petrolatum Dressing |
Roosin Medical Co., Ltd |
Charles Shen |
| K192030 |
09/19/2019 |
RS80 EVO Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K183675 |
09/25/2019 |
3D Visualization System |
Scivita Medical Technology Co., Ltd |
Ruqin Wu |
| K192011 |
09/25/2019 |
PhoeniX |
Sedecal, SA. |
M¬ Luisa Gomez de Aguero |
| K190002 |
09/12/2019 |
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 Co., Ltd |
Yibing Wang |
| K192293 |
09/12/2019 |
uDR 592h, uDR 596i |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K190466 |
09/26/2019 |
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. |
Cheryl Reep |
| K190869 |
09/13/2019 |
Pulse Oximeter |
Shenzhen Aeon Technology Co., Ltd. |
Xie Hua |
| K192301 |
09/20/2019 |
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K182751 |
09/06/2019 |
Reusable Temperature Probe |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K191253 |
09/17/2019 |
Reusable NIBP Cuff |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K191518 |
09/12/2019 |
CO2 Laser System |
Shenzhen GSD Tech Co., Ltd |
Jiancheng Zhang |
| K191531 |
09/06/2019 |
Sure-Fine Insulin Syringes |
Shina Med Corporation |
Park Sung-soon |
| K190780 |
09/12/2019 |
syngo Application Software |
Siemens Medical Solution USA, Inc. |
Patricia D. Jones |
| K183268 |
09/10/2019 |
AI-Rad Companion (Cardiovascular) |
Siemens Medical Solutions USA, Inc. |
Kimberly Rendon |
| K190768 |
09/12/2019 |
ARTIS icono |
Siemens Medical Solutions USA, Inc. |
Patricia D. Jones |
| K192402 |
09/20/2019 |
syngo.CT Extended Functionality |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K192065 |
09/18/2019 |
Syngo.Via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K190049 |
09/17/2019 |
Sim&Size |
Sim&Cure |
Krishna Mahadea |
| K191366 |
09/06/2019 |
Vacutore Air/Water Bottle Tubing |
Smartdata Suzhou Co., Ltd |
Cindy Ye |
| K192155 |
09/04/2019 |
Smith & Nephew DYONICS 25 Fluid Management System |
Smith & Nephew, Inc. |
Bryan Cowell |
| K191421 |
09/09/2019 |
Sofacia System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K190563 |
09/18/2019 |
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. |
Il Kim |
| K192322 |
09/23/2019 |
T-Stat 2.0 Microvascular Tissue Oximeter |
Spectros Corporation |
Bill Curnan |
| K191576 |
09/16/2019 |
Mercury« Spinal System, Overwatch« Spinal System |
Spinal Elements, Inc |
Julie Lamothe |
| K191726 |
09/12/2019 |
mont blanc & mont blanc MIS Spinal Systems |
Spineway SA |
Heloise Macaire |
| K183027 |
09/06/2019 |
Steerable catheter control system |
Stereotaxis, Inc. |
Kenneth H. Lock |
| K190005 |
09/13/2019 |
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer |
Sterilucent, Inc. |
Peter Kalkbrenner |
| K192020 |
09/05/2019 |
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label |
STERIS Corporation |
Gregory Land |
| K191343 |
09/05/2019 |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 |
STERIS Corporation |
Jennifer Nalepka |
| K192172 |
09/09/2019 |
Connected OR Hub with Device and Voice Control |
Stryker |
Meagan Jones |
| K191102 |
09/06/2019 |
Precision S 4K Sinuscope |
Stryker |
Jessie Duong |
| K191688 |
09/16/2019 |
SubtleMR |
Subtle Medical, Inc. |
Ajit Shankaranarayanan |
| K192304 |
09/13/2019 |
SIS Software Version 3.6.0 |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K191617 |
09/03/2019 |
Syntec Tibial Nail System |
Syntec Scientific Corporation |
Kavin Chu |
| K183436 |
09/18/2019 |
OraCure |
TBM Corporation |
Jae-woong Jeong |
| K190830 |
09/13/2019 |
TDM Screw Systems |
TDM Co. Ltd. |
Youngdae Kim |
| K191021 |
09/13/2019 |
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye |
Terragene SA |
Maria Victoria Rocha |
| K192116 |
09/04/2019 |
Human IgA liquid reagent kit for Use on SPAPlus |
The Binding Site Group Ltd |
Natasha Verhaak |
| K191297 |
09/17/2019 |
iNSitu Bipolar Hip System |
Theken Companies, LLC |
Garrett Spurgeon |
| K190001 |
09/20/2019 |
Supercath 5 |
TOGO MEDIKIT Co., Ltd. |
Daisuke Nagamizu |
| K182765 |
09/03/2019 |
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 |
Sho Yokoya |
| K191791 |
09/25/2019 |
TranS1 Interbody Fusion System |
TranS1 |
Kristen Allen |
| K190024 |
09/27/2019 |
Smart-C |
Turner Imaging Systems, Inc. |
Michael Drake |
| K191929 |
09/17/2019 |
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens |
UNICON Optical CO., LTD |
Hsiao-Wei Shen |
| K190858 |
09/18/2019 |
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant |
United Consortium |
Stephanie Morris |
| K190100 |
09/23/2019 |
USTAR II System |
United Orthopedic Corporation |
Lois Ho |
| K192059 |
09/17/2019 |
Bio Guard Air/Water & Suction Valves |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K182257 |
09/12/2019 |
UPnRIDE |
UPnRIDE Robotics Ltd. |
Yoram Levy |
| K190683 |
09/10/2019 |
External Counterpulsation System |
Vamed Medical Instrument Co., Ltd |
Ji Mia |
| K191528 |
09/06/2019 |
Venus Legacy Pro Device |
Venus Concept USA Inc. |
Yoni Iger |
| K191676 |
09/16/2019 |
Intra.Ox 2.0 Handheld Tissue Oximeter |
ViOptix, Inc. |
Scott Coleridge |
| K183670 |
09/13/2019 |
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 |
Evan Huang |
| K182292 |
09/18/2019 |
VORTRAN APM-Plus |
VORTRAN Medical Technology 1, Inc. |
James Lee |
| K191273 |
09/13/2019 |
Multi-Link X2 ECG and SpO2 Adapter |
Vyaire Medical, Inc. |
Suzanne Moreno |
| K191013 |
09/10/2019 |
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option |
Welch Allyn, Inc. |
Megan Pellenz |
| K192425 |
09/30/2019 |
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp |
Won Tech Co., Ltd. |
Jake Yu |
| K183563 |
09/05/2019 |
Holinwon 30 |
Won Tech Co., Ltd. |
Jake Yu |
| K191074 |
09/27/2019 |
Sorrento Bone Graft Substitute |
Xenco Medical, LLC |
Jason Haider |
| K191354 |
09/09/2019 |
Ti3Z Cervical Interbody System |
Zavation Medical Products, LLC |
Katie Motley |
| K191619 |
09/11/2019 |
TurboTemp EZ |
Zest Anchors, LLC |
Marysa E. Loustalot |
| K192217 |
09/13/2019 |
NCB Plating System Distal Femur and Proximal Tibia |
Zimmer GmbH |
Annemie Rehor Kausch |
| K191625 |
09/05/2019 |
Persona Revision Knee System |
Zimmer Inc. |
Nicole Meredith |
