| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K192192 |
08/13/2019 |
VSP System |
3D Systems |
Kim Torluemke |
| K192119 |
08/06/2019 |
3M Clarity Aligners |
3M Company |
Yanine Garcia-Quezada |
| K192305 |
08/23/2019 |
Colibri Endoscopy System |
3NT Medical Ltd. |
Ehud Bendory |
| K192140 |
08/08/2019 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K192272 |
08/22/2019 |
Wolf445nm |
A.R.C. Laser GmbH |
Angela Thyzel |
| K192267 |
08/21/2019 |
ILUMIEN System with AptiVue Software version D.3 |
Abbott Medical |
Anita Xavier |
| K192175 |
08/12/2019 |
On Call Express II Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K192106 |
08/05/2019 |
AcQRef Introducer Sheath |
Acutus Medical, Inc. |
Serena Sanginthirath |
| K192056 |
08/01/2019 |
JJ Series Container System |
Aesculap, Inc. |
Sierra Mertz |
| K192266 |
08/21/2019 |
M. Blue Adjustable Shunt System |
Aesculap, Inc. |
Kathy A Racosky |
| K192231 |
08/16/2019 |
Dental Glass Ceramics Blocks |
Aidite (Qinhuangdao) Technology Co., Ltd. |
Zhang Wei |
| K192383 |
08/30/2019 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K192102 |
08/05/2019 |
Thermoplastic Masks |
Aktina Medical Corporation |
Tony Spaccarotella |
| K192088 |
08/05/2019 |
GOLNIT Non-aborbable PTFE Surgical Suture |
Antarma LLC dba Golnit Sutures |
Armine Badalyan |
| DEN190037 |
08/13/2019 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule |
AnX Robotica, Inc. |
David Duan |
| K192244 |
08/19/2019 |
Arcad SmileStudio and Aligner System |
ArcadLab |
Emerson Cano |
| K192238 |
08/19/2019 |
AC3 Series Intra-Aortic Balloon Pump (IABP) |
Arrow International, Teleflex |
Deb Fleetham |
| K192372 |
08/30/2019 |
ASCEND Image Viewer |
Ascend Hit |
Andy Miller |
| K192357 |
08/29/2019 |
INNOVO |
Atlantic Therapeutics Ltd. |
Anne-Marie Keenan |
| K192125 |
08/06/2019 |
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen |
AtriCure, Inc |
Johnathon McElwee |
| K192318 |
08/26/2019 |
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters |
Bard Peripheral Vascular, Inc. |
Andrew Quach |
| K192363 |
08/30/2019 |
Altapore |
Baxter Healthcare Corporation |
Phillip Romei |
| K192366 |
08/30/2019 |
Intravascular Extension Sets and Accessories |
Baxter Healthcare Corporation |
Gary Chumbimune |
| DEN190040 |
08/27/2019 |
Caption Guidance |
Bay Labs, Inc. |
Sam Surette |
| K192370 |
08/30/2019 |
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation |
Bayer Medical Care, Inc. |
Alison Maloney |
| K192271 |
08/22/2019 |
Access PCT, Access PCT Calibrators |
Beckman Coulter, Inc. |
Jennifer Bennett |
| K192355 |
08/29/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K192295 |
08/23/2019 |
PDT-FACE |
Beijing ADSS Development Co., Ltd. |
Su CuiYing |
| K192274 |
08/22/2019 |
BV Dental Implant System |
Bio Concept Co., Ltd |
Xiaodong Dai |
| K192234 |
08/19/2019 |
ActiPatch |
BioElectronics Corporation |
Sree N. Koneru |
| K192110 |
08/05/2019 |
Vitek Densichek |
bioMerieux, Inc |
Jennifer Jines |
| K192246 |
08/19/2019 |
Biowy PICC Catheter S Kit |
Biowy Corporation |
Arthur Lu |
| DEN190038 |
08/15/2019 |
Surfacer Inside-Out Access Catheter System |
Bluegrass Vascular Technologies, Inc. |
Gabriele G. Niederauer |
| K192360 |
08/30/2019 |
IntellaMap Orion High Resolution Mapping Catheter |
Boston Scientific Corporation |
Nicole Lyden |
| K192145 |
08/08/2019 |
Galileo Vertebral Body Replacement Device |
Bright Spine |
Robert Simonson |
| K192224 |
08/16/2019 |
BTL-899 |
BTL |
David Chmel |
| K192313 |
08/26/2019 |
Halo One Thin-Walled Guiding Sheath |
C.R. Bard, Inc. |
Elizabeth Delahunty |
| K192239 |
08/19/2019 |
WavelinQ Plus EndoAVF System |
C.R. Bard, Inc. |
Kulveen Dhatt |
| K192188 |
08/13/2019 |
Aquilion ONE (TSX-306A/3) V10.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K192199 |
08/13/2019 |
CRC PC Smart Chamber K1 |
Capintec, Inc. |
Mary Anne Yusko |
| K192214 |
08/15/2019 |
CarboClear VBR System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K192374 |
08/30/2019 |
Cardinal HealthÖ Level 3 Surgical Mask with Anti-Fog Foam Strip |
Cardinal Health 200, LLC |
Dominic Tunzi |
| K192156 |
08/09/2019 |
Cartiva SCI instrumentation set |
Cartiva, Inc. |
Shriya Kafle |
| K192251 |
08/20/2019 |
Livento Press, Soprano 10, Soprano |
Cendres+Metaux SA |
Andrea Sparti |
| K192113 |
08/05/2019 |
DRSplus |
CenterVue SpA |
Roberto Gabriotti |
| K192168 |
08/09/2019 |
Idys ALIF ZP 3DTi |
CLARIANCE, SAS |
Fadwa Bahr |
| K192107 |
08/05/2019 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Brendan Seward |
| K192129 |
08/07/2019 |
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 |
| K192198 |
08/13/2019 |
Conformis Hip System |
Conformis, Inc. |
Paul Smolenski |
| K192114 |
08/06/2019 |
Game Ready GRPro 2.1 System |
Cool Systems, Inc. (dba Game Ready) |
Natalie Kennel |
| K192330 |
08/27/2019 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Sarah Tang |
| K192302 |
08/23/2019 |
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter |
Covidien, llc |
Carol S Ming |
| K192228 |
08/16/2019 |
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 |
08/09/2019 |
CuraRad-ICH |
CuraCloud Corp. |
Xiaoxiao Liu |
| K192262 |
08/21/2019 |
Dental Zirconia Blocks |
De Corematrix Co.Ltd. |
Kaixuan Liu |
| K192165 |
08/09/2019 |
Acteon Imaging Suite |
de Gotzen S.R.L |
Dario Bandiera |
| K192149 |
08/09/2019 |
MIS Dental Implant System |
Dentsply Sirona Inc. |
Karl J. Nittinger |
| K192273 |
08/22/2019 |
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit |
Diadent Group International |
Kab Sun Lee |
| K192284 |
08/22/2019 |
DiaFil Flow |
Diadent Group International |
Kab Sun Lee |
| K192158 |
08/09/2019 |
DiaTemp |
Diadent Group International |
Kab Sun Lee |
| K192064 |
08/01/2019 |
LIAISON Vitamin B12 |
DiaSorin Inc. |
John C. Walter |
| K192376 |
08/30/2019 |
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K192337 |
08/28/2019 |
Zeroveno |
Dimedi Co., Ltd. |
Nam Youn |
| K192263 |
08/21/2019 |
UCLA CCM Abutment |
DIO Corporation |
Jiae Park |
| K192190 |
08/13/2019 |
Solax Electric Scooter |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K192364 |
08/30/2019 |
GXR-Series Diagnostic X-Ray System |
DRGEM Corporation |
Ki-Nam Yang |
| K192069 |
08/01/2019 |
Aerodentis System |
Dror Orthodesign |
Michael Nadav |
| K192058 |
08/01/2019 |
EV1000 Clinical Platform NI, EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
Christine Chun |
| K192242 |
08/19/2019 |
Synergy Platform, Synergy, Infinity, VersaHD |
Elekta Limited |
Irina Proutski |
| K192170 |
08/12/2019 |
VistaScan USB Ultrasound Imaging System |
Emagine Solutions Technology, LLC |
Courtney Williams |
| K192300 |
08/23/2019 |
EnlightenVue Microendoscopy System |
EnlightenVue, Inc. |
Giacomo Basadonna |
| K192079 |
08/02/2019 |
EOSedge |
EOS imaging |
Bernard Ismael |
| K192075 |
08/02/2019 |
ProSealÖ Closed System drug Transfer Device (CSTD) |
Epic Medical Pte. Ltd. |
Freddie Lee |
| K192157 |
08/09/2019 |
6450 Ultrasound system |
Esaote, S.p.A. |
Piet DeJong |
| K192144 |
08/08/2019 |
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device |
Ethicon, Inc. |
Eleanor Zhou |
| K192098 |
08/05/2019 |
EzMobile |
Ewoosoft Co., Ltd. |
Young Seok Kim |
| K192303 |
08/23/2019 |
ExactVu High Resolution Micro-Ultrasound System |
Exact Imaging Inc. |
Sam Rajkumar |
| K192097 |
08/05/2019 |
Exactech« Equinoxe« Stemless Humeral Components |
Exactech, Inc. |
Zach Sharrah |
| K192161 |
08/09/2019 |
FastFit EMS System |
Fast Fit LLC |
Lisa Falcone |
| K192210 |
08/14/2019 |
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System |
Fiab SpA |
Francesco Batistini |
| K192285 |
08/22/2019 |
CPR Face Shield |
Firstar Healthcare Company Limited (Guangzhou) |
Alice Zhao |
| K192371 |
08/30/2019 |
BioZorb SP Marker |
Focal Therapeutics |
Dhaval Saraiya |
| K192233 |
08/19/2019 |
LED Curing Light |
Foshan CICADA Dental Instrument Co., Ltd. |
Juan Liu |
| K192150 |
08/09/2019 |
AMICUS Separator System |
Fresenius Kabi AG |
Aunica Jones |
| K192368 |
08/30/2019 |
CATSmart |
Fresenius Kabi AG |
Shane Sawall |
| K192209 |
08/14/2019 |
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K192346 |
08/29/2019 |
scaffolene CL100 Bioresorbable Collagen Matrix |
Freudenberg Technology Innovation SE & Co. KG |
Denis Reibel |
| K192286 |
08/22/2019 |
FUJIFILM EP-6000 Video Processor |
FUJIFILM Corporation |
Randy Vader |
| K192380 |
08/30/2019 |
ST AIA-PACK BNP |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K192323 |
08/27/2019 |
PolyLock Small Bone Plating System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K192206 |
08/14/2019 |
32mm Glenosphere and Humeral Cup |
FX Shoulder USA, Inc. |
Kathy Trier |
| K192195 |
08/13/2019 |
Sterile Dilator |
Galt Medical Corp. |
David Derrick |
| K192260 |
08/21/2019 |
everX Flow |
GC America Inc. |
Mark Heiss |
| K192159 |
08/09/2019 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| K192277 |
08/22/2019 |
CardIQ Flow |
GE Medical Systems SCS |
Elizabeth Mathew |
| K192076 |
08/02/2019 |
Binary« Anterior Cervical Plate System |
Genesys Spine |
Andrew C. Davison C. Davison |
| K192314 |
08/26/2019 |
RESONATE Anterior Cervical Plate System |
Globus Medical Inc. |
Kelly J Baker |
| K192115 |
08/06/2019 |
SABLE Expandable Spacer |
Globus Medical Inc. |
Kelly J. Baker |
| K192269 |
08/21/2019 |
TwinScan 808/755 Laser System |
GME German Medical Engineering GmbH |
Stefan Schulze |
| K192335 |
08/28/2019 |
TRACKER Kyphoplasty System |
GS Medical Co., Ltd. |
Andrea Watt |
| K192201 |
08/13/2019 |
Electrical Stimulator System |
Gymmax Technology Shenzen Co., Ltd. |
Benson Wang |
| K192342 |
08/28/2019 |
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) |
Hangzhou AGS MedTech Co., Ltd. |
Chunqi Han |
| K192326 |
08/27/2019 |
HardyDisk AST Lefamulin 20╡g (LMU20) |
Hardy Diagnostics |
Anna Klavins |
| K192232 |
08/16/2019 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) |
Hartalega NGC Sdn. Bhd. |
Kuan Mun Leong |
| K192073 |
08/02/2019 |
Helix Genetic Health Risk App for late-onset AlzheimerÆs disease |
Helix OpCo, LLC |
Gloria Lee |
| DEN190035 |
08/02/2019 |
Helix Laboratory Platform |
Helix OpCo, LLC |
Gloria Lee |
| K192143 |
08/08/2019 |
Maximus System |
Hill-Rom Services Pte Ltd |
Alvin Tan |
| K192264 |
08/21/2019 |
HIVOX Spopad EMS SP-911, SP-921 |
Hivox Biotek Inc. |
Marx Lee |
| DEN190039 |
08/22/2019 |
ToothWaveÖ |
Home Skinovations Ltd. |
Amit Goren |
| K192082 |
08/02/2019 |
Droplet Pen Needle 34G |
HTL-Strefa S.A |
Aleksandra Prazmowska-Wilanowska |
| K192294 |
08/23/2019 |
I Do |
I Do Biotech Co., Ltd |
Jae-Hyung Song |
| K192220 |
08/15/2019 |
ReliOn Premier Classic Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K192109 |
08/05/2019 |
KOALA |
IB Lab GmbH |
Richard Ljuhar |
| K192130 |
08/07/2019 |
Icobrain |
Icometrix NV |
Dirk Smeets |
| K192154 |
08/09/2019 |
Rio Vial-to-Bag Drug Reconstitution Device |
ICU Medical |
Sheila Antonio |
| K192178 |
08/12/2019 |
R&D Series Nova Compo N |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Husamettin Sonmez |
| K192084 |
08/02/2019 |
Madison Total Knee System |
Implanet, S.A. |
Regis Le Couedic |
| K192218 |
08/15/2019 |
Custom Legacy and Custom InterActive Titanium Abutments |
Implant Direct Sybron Manufacturing , LLC |
Reina Choi |
| K192221 |
08/15/2019 |
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K192332 |
08/27/2019 |
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
Eben Gordon |
| K192249 |
08/19/2019 |
InMode System with Tone Applicator |
InMode Ltd. |
Amit Goren |
| K192197 |
08/13/2019 |
Magicore II System |
InnoBioSurg Co., Ltd. |
Eun-Ji Yoo |
| K192105 |
08/05/2019 |
Innonix Antiviral Child's Face Mask |
Innonix Technologies Limited |
Tommy Lui |
| K192354 |
08/29/2019 |
Innovasis Gibralt Spine System |
Innovasis, Inc. |
Marshall McCarthy |
| K192176 |
08/12/2019 |
IntelePACS |
Intelerad Medical Systems Incorporated |
Luce Caron |
| K192112 |
08/05/2019 |
FlexBand Plus |
International Life Sciences |
Tiffini Wittwer |
| K192367 |
08/30/2019 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
Jennifer Siu |
| K192216 |
08/15/2019 |
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP |
Invacare Corporation |
Elijah Wreh |
| K192200 |
08/13/2019 |
DynaCAD |
Invivo Corporation |
Kym Rupp |
| K192275 |
08/22/2019 |
invisa-RED ELITE |
IR Technology LLC |
Thomas A. Namynanik |
| K192289 |
08/23/2019 |
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit |
IRRAS USA, Ltd. |
Vinny Podichetty |
| K192369 |
08/30/2019 |
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit |
iXensor Co. Ltd. |
Evita Chen |
| K192229 |
08/16/2019 |
Neodent Implant System- GM Titanium Base for Bridge |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K192329 |
08/27/2019 |
Blue Latex Examination Powder Free Gloves |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Surbramaniam |
| K192333 |
08/27/2019 |
Blue Nitrile Examination Gloves Powder Free |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Sburamaniam |
| K192328 |
08/27/2019 |
JR.MEDIK Latex SurgeonÆs Gloves Powder Free |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Subramaniam |
| K192068 |
08/01/2019 |
i-ED COIL |
Kaneka Pharma America LLC |
Kazuhiko Inoue |
| K192090 |
08/05/2019 |
CMOS Video Rhino-Laryngoscope SSU |
Karl Storz SE & Co. KG |
Alexey Davidov |
| K192196 |
08/13/2019 |
Medical Radiation Dosimetry System microSTARii |
Landauer |
Matt Ennis |
| K192208 |
08/14/2019 |
CORNICE Cervical Spacer System |
Legend Spine Technologies |
Steve Marinelli |
| K192235 |
08/19/2019 |
AEON Laparoscopic Instruments |
Lexington Medical, Inc. |
Douglas MacBride |
| K192325 |
08/27/2019 |
Quantum Blood and Fluid Warming System |
Life Warmer, Inc. |
John Pettini |
| K192299 |
08/23/2019 |
LZI Cotinine II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K192345 |
08/29/2019 |
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K192331 |
08/27/2019 |
LaseMD LEO Laser System |
Lutronic Global |
James Childs |
| K192247 |
08/19/2019 |
Steripath Gen2 Blood Collection System |
Magnolia Medical Technologies, Inc. |
Gregory J Bullington |
| K192148 |
08/08/2019 |
Freedom Primary PCK |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K192126 |
08/06/2019 |
AMIStem-P Short Neck |
Medacta International SA |
Stefano Baj |
| K192352 |
08/29/2019 |
MiniMAX |
Medacta International SA |
Stefano Baj |
| K192297 |
08/23/2019 |
APTUS Wrist Arthrodesis Plates |
Medartis AG |
Andrea Kiefer-Schweizer |
| K192099 |
08/05/2019 |
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 |
08/05/2019 |
Medone Ultra, Medextra |
Medax Srl Unipersonale |
Stefano Cavalieri |
| K192282 |
08/22/2019 |
MedCAD« AccuPlan« System |
MedCAD |
Brian Buss |
| K192230 |
08/16/2019 |
MF SAFECATH |
MediFirst Co., Ltd. |
Ha Tae Joo |
| K192100 |
08/05/2019 |
Aveta Disposable Hysteroscope |
Meditrina, Inc. |
Csaba Truckai |
| K192315 |
08/26/2019 |
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Claire Pigman |
| K192104 |
08/05/2019 |
Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Claire Pigman |
| K192281 |
08/22/2019 |
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoli |
Medos International SARL |
Sergio M. Cordeiro |
| K192283 |
08/22/2019 |
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator |
Medron, LLC |
David Kujawa |
| K192173 |
08/12/2019 |
ROSA ONE Spine application |
MEDTECH S.A. |
Serge Tabet |
| K192336 |
08/28/2019 |
Navigated Anterolateral Disc Prep Instruments |
Medtronic Sofamor Danek USA, INC. |
Parwinder Singh |
| K192296 |
08/23/2019 |
Medtronic 6F Taiga Guiding Catheter |
Medtronic Vascular |
Colleen Mullins |
| K192347 |
08/29/2019 |
ST Internal Implant System |
Megagen Implant Co. Ltd |
You Jung Kim |
| K192252 |
08/20/2019 |
ProPerformance Recovery System |
Menlo Brands LLC |
Sam Chi |
| K192276 |
08/22/2019 |
Merge Cardio |
Merge Healthcare Incorporated |
Lisa Baumhardt |
| K192182 |
08/12/2019 |
C015 |
Micronica SRL |
Massimo Tomasi |
| K192135 |
08/07/2019 |
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) |
MicroVention, Inc. |
Sapna Singh |
| K192268 |
08/21/2019 |
Europa Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K192186 |
08/12/2019 |
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph |
Neurolign USA, LLC |
Aura Kullmann |
| K192248 |
08/19/2019 |
CortinaÖ [MAX] Lumbar Cage System |
NeuroStructures, Inc. |
Moti Altarac |
| K192162 |
08/09/2019 |
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate |
NeuroVention LLC |
Rohit Khanna |
| K192338 |
08/28/2019 |
NEOLab Clear Aligners |
New England Ortho Lab, Inc. |
Olivia Channon |
| K192153 |
08/09/2019 |
Portux CAD/CAM Disc |
New Stetic S.A. |
Juan David Jaramillo G. |
| K192349 |
08/29/2019 |
Bactisure Wound Lavage |
Next Science, LLC |
Jeanne Lee |
| K192307 |
08/26/2019 |
Nihon Kohden NKV-550 Series Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Sheryl Higgins |
| K192291 |
08/23/2019 |
TidalPort-AP Implantable Apheresis Vascular Access Port |
Norfolk Medical Products, Inc. |
Natan Pheil |
| K192174 |
08/12/2019 |
SPY Portable Handheld Imaging (SPY-PHI) System |
Novadaq Technologies ULC. (now a part of Stryker) |
Agatha Szeliga |
| K192356 |
08/29/2019 |
Airlock Centrolock Osteosynthesis Implant System |
NOVASTEP |
Gilles Audic |
| K192181 |
08/12/2019 |
PRECICE Plating System |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K192241 |
08/19/2019 |
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
O & M Haylard, Inc. |
Steven Dowdley |
| K192362 |
08/30/2019 |
Aero Blue Performance Surgical Gowns |
O&M Halyard, Inc. |
Kimberly Lewis |
| K192083 |
08/02/2019 |
Okami Medical LOBO Vascular Occlusion System |
Okami Medical |
Rebecca K Pine |
| K192164 |
08/09/2019 |
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K192103 |
08/05/2019 |
Thunderbeat Open Fine Jaw Type X Hand Instrument |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K192096 |
08/05/2019 |
Omnia Medical Trauma Screws |
Omnia Medical, LLC |
Troy Schifano |
| K192340 |
08/28/2019 |
OptoMonitor |
Opsens Inc |
Marc Chaunet |
| K192344 |
08/29/2019 |
Sapphire NC Plus Coronary Dilatation Catheter |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K192279 |
08/22/2019 |
PhantomMSK Trauma |
OrthoGrid Systems Inc. |
Sebastian Edin |
| K192080 |
08/02/2019 |
iASSIST Knee System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Eduardo Mendoza |
| K192074 |
08/02/2019 |
Signature ONE System |
Orthosoft, Inc. (d/b/a Zimmer CAS) |
Paul Hardy |
| K192379 |
08/30/2019 |
Hi-Fatigue G Bone Cement |
OSARTIS GmbH |
Volker Stirnal |
| K192310 |
08/26/2019 |
Flap Fixator, Burr Hole Cover |
Ossaware Biotech Co., Ltd. |
Meng Feng Huang |
| K192121 |
08/06/2019 |
Black Diamond Pedicle Screw System |
Osseus Fusion Systems |
Robert Pace |
| K192147 |
08/08/2019 |
Halyard ONE-STEP* Sterilization Wrap |
Owens & Minor (O&M) Halyard, Inc |
Steven Dowdley |
| K192108 |
08/05/2019 |
Panthera Dental Milled Bars |
Panthera Dental Inc. |
Martine Fortin |
| K192163 |
08/09/2019 |
TTC Phantom« Intramedullary Nail System |
Paragon 28, Inc. |
Haylie Hertz |
| K192280 |
08/22/2019 |
PENTAX Medical ED-3490TK Video Duodenoscope |
Pentax Medical |
William Goeller |
| K192245 |
08/19/2019 |
Pentax Medical Video Duodenoscope ED34-i10T2 |
PENTAX of America, Inc. |
William Goeller |
| K192063 |
08/01/2019 |
PGDx elio tissue complete |
Personal Genome Diagnostics |
Jennifer Dickey |
| K192259 |
08/21/2019 |
Philips IntelliSite Pathology Solution |
Philips Electronics Nederland B.V. |
Liselotte Kornmann |
| K192226 |
08/16/2019 |
Lumify Diagnostic Ultrasound System |
Philips Healthcare |
Paul Elias |
| K192137 |
08/07/2019 |
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 |
Philips Medizin Systeme Boeblingen GmbH |
Stefan Breuer |
| K192317 |
08/26/2019 |
Planmed Clarity 2D and Clarity S |
Planmed Oy |
Lars Moring |
| K192222 |
08/16/2019 |
EZ-Inject Single use Needle |
POONGLIM Pharmatech Inc. |
Cho Hee Min |
| K192183 |
08/12/2019 |
RocaTub Ureteral Catheter |
Promepal Sam |
Mohamed Rekik |
| K192169 |
08/09/2019 |
PulsioFlex Monitoring System with ProAQT Sensor |
Pulsion Medical Systems SE |
Tobias Klaempfl |
| K192123 |
08/06/2019 |
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream |
Qingdao Hightop Biotech Co., Ltd. |
Allen Lee |
| K192254 |
08/20/2019 |
InnoSight Diagnostic Ultrasound System |
Qisda Corporation |
Johnson Sheu |
| K192160 |
08/09/2019 |
EVO Platform |
Quanta System, S.p.A |
Francesco Dell'Antonio |
| K192138 |
08/08/2019 |
Rejuvapen NXT |
Refine USA LLC |
Brian Smith |
| K192270 |
08/22/2019 |
LEva Pelvic Digital Health System |
Renovia Inc. |
Gina Prochilo-Cawston |
| K192127 |
08/06/2019 |
Respire Pink AT (Hard, Hard/Soft, EF) |
Respire Medical Holdings |
Madubuike Okafor |
| K192072 |
08/02/2019 |
Tina-quant C-Reactive Protein IV |
Roche Diagnostics Operations (RDO) |
Barbara Ann McWhorter |
| K192319 |
08/26/2019 |
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K192062 |
08/01/2019 |
Nucleoss T6 Dental Implant System |
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St |
Ezgi Ozbudak |
| K192316 |
08/26/2019 |
Matrix HA PEEK Cervical Implant System |
Sapphire Medical Group |
Anthony Ruggiero |
| K192381 |
08/30/2019 |
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor |
Scientific Pharmaceuticals |
Thomas Kelly |
| K192287 |
08/22/2019 |
Transpara |
Screenpoint Medical B.V. |
Umar Waqas |
| K192132 |
08/07/2019 |
SeaSpine Beachside System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K192095 |
08/05/2019 |
CAPI 3 Immunotyping, Capillarys 3 Tera |
Sebia |
Karen Anderson |
| K192092 |
08/05/2019 |
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 |
Seca GmbH & Co. Kg |
Corinna Hatje |
| K192118 |
08/06/2019 |
CRP Vario |
Sentinel CH, Spa |
Patricia Dupe |
| K192179 |
08/12/2019 |
Oral/Enteral Syringe |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Weixin Zhang |
| K192293 |
08/23/2019 |
uDR 592h, uDR 596i |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K192301 |
08/23/2019 |
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K192343 |
08/28/2019 |
Patient Monitor |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K192152 |
08/09/2019 |
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Zhang Wei |
| K192087 |
08/05/2019 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
Kevin Zhang |
| K192365 |
08/30/2019 |
Shoulder Innovations Total Shoulder System |
Shoulder Innovations Inc |
Don Running |
| K192348 |
08/29/2019 |
SICAT Implant V2.0 |
SICAT GmbH & Co. KG |
Manfred Breuer |
| K192240 |
08/19/2019 |
RAPIDPoint 500e Blood Gas System |
Siemens Healthcare Diagnostics, Inc. |
Lois Parillon |
| K192061 |
08/01/2019 |
SOMATOM Go Platform û SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K192065 |
08/01/2019 |
Syngo.Via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K192155 |
08/09/2019 |
Smith & Nephew DYONICS 25 Fluid Management System |
Smith & Nephew, Inc. |
Bryan Cowell |
| K192375 |
08/30/2019 |
Intellifuse Administration and Intellifuse Blood Administration Sets |
Smiths Medical ASD, Inc. |
Wendy Hills |
| K192253 |
08/20/2019 |
SonicEye Dual-Array Ultrasound System |
Sonivate Medical Inc |
Steve Hesler |
| K192211 |
08/14/2019 |
SoundBite Console, SoundBite Active Wire 18 |
SoundBite Medical Solution Inc. |
Marc Andre Cote |
| K192322 |
08/27/2019 |
T-Stat 2.0 Microvascular Tissue Oximeter |
Spectros Corporation |
Bill Curnan |
| K192382 |
08/30/2019 |
CapKlenZ |
Star Mountain Medical, Inc. |
Aaron Chiu |
| K192172 |
08/12/2019 |
Connected OR Hub with Device and Voice Control |
Stryker |
Meagan Jones |
| K192292 |
08/23/2019 |
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable |
Stryker |
April Malmborg |
| K192207 |
08/14/2019 |
Trevo NXT ProVue Retriever |
Stryker |
Rhoda M Santos |
| K192122 |
08/06/2019 |
Trevo Trak 21 Microcatheter |
Stryker |
Rhoda Santos |
| K192304 |
08/23/2019 |
SIS Software Version 3.6.0 |
Surgical Information Sciences, Inc. |
Ann Quinlan-Smith |
| K192128 |
08/07/2019 |
Sutter Arrowtip Monopolar Electrodes |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K192327 |
08/27/2019 |
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile |
Synthes (USA) Products LLC |
Thomas Shea |
| K192177 |
08/12/2019 |
SysMed S/T |
SysMed (China) Co., Ltd |
Yue Jian |
| K192324 |
08/27/2019 |
Sheridan Spiral-Flex Endotracheal Tubes |
TeleflexMedical, Inc |
Lori Pfohl |
| K192057 |
08/01/2019 |
K-Pack II Needle - 27G x 1/2ö Extra Thin Wall, K-Pack II Needle - 27G x 1/2ö Ultra Thin Wall, K-Pack II Needle - 30G x 1/2ö Extra Thin Wall, K-Pack II Needle - 30G x 1/2ö Ultra Thin Wall |
Terumo Europe N.V. |
M. J. Aerts |
| K192116 |
08/06/2019 |
Human IgA liquid reagent kit for Use on SPAPlus |
The Binding Site Group Ltd |
Natasha Verhaak |
| K192071 |
08/02/2019 |
iNSitu Total Hip System |
Theken Companies, LLC |
Garrett Spurgeon |
| K192250 |
08/19/2019 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K192111 |
08/05/2019 |
Biodegradable Nitrile Examination Powder Free Glove, Green |
Top Glove SDN BHD |
Noor Akilah Saidin |
| K192117 |
08/06/2019 |
Small VBRÖ |
ulrich GmbH & Co. KG |
Christoph Ulrich |
| K192185 |
08/12/2019 |
The Cellfina System |
Ulthera, Inc |
Lisa Pray |
| K192203 |
08/14/2019 |
JO for Him H2O Gel Original Personal Lubricant |
United Consortium |
Stephanie Morris |
| K192265 |
08/21/2019 |
gi-4000 Electrosurgical Generator |
United States Endoscopy Group, Inc |
Carroll L. Martin |
| K192059 |
08/01/2019 |
Bio Guard Air/Water & Suction Valves |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K192124 |
08/06/2019 |
Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories |
US Medical Innovations, LLC |
David Hinds |
| K192278 |
08/22/2019 |
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) |
UVision360 Inc. |
Allison London Brown |
| K192204 |
08/14/2019 |
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, |
Valencia Naturals Inc. |
Louie Goryoka |
| K192377 |
08/30/2019 |
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon |
Varian Medical Systems, Inc. |
Peter J Coronado |
| K192120 |
08/06/2019 |
Venner PneuXÖ ETT (Endotracheal Tube) 6 mm, Venner PneuXÖ ETT (Endotracheal Tube) 7 mm, Venner PneuXÖ ETT (Endotracheal Tube) 8 mm, Venner PneuXÖ ETT (Endotracheal Tube) 9 mm |
Venner Medical (Singapore) Pte Ltd |
Adrian P Waterton |
| K192146 |
08/08/2019 |
V-DENUPET |
Vitromed GmbH |
Deepesh Changat |
| K192225 |
08/16/2019 |
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses |
VizionFocus, Inc. |
Angus Shih |
| K192077 |
08/02/2019 |
Tua Face Fitness / Tua Trend Face |
Vupiesse S.R.L |
Marco Paolizzi |
| K192339 |
08/28/2019 |
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord |
Wilson-Cook Medical, Inc. |
Marge Walls-Walker |
| K192350 |
08/29/2019 |
Medical Non-Ablative Fractional Laser Systems |
Wingderm Electro-Optics Ltd. |
Zhou Juan |
| K192202 |
08/14/2019 |
Clear21 |
World Class Technology Corporation |
Alan Kozlowski |
| K192308 |
08/26/2019 |
Wu's Electrical Scooter |
Wu's Tech Co., Ltd. |
Jen Ke-Min |
| K192358 |
08/29/2019 |
Pressure Therapy System PT1003 |
Xiamen Senyang Co., Ltd. |
Nina Cai |
| K192290 |
08/23/2019 |
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 |
| K192320 |
08/26/2019 |
HealthCXR |
Zebra Medical Vision, Ltd. |
Flair Bar |
| K192258 |
08/20/2019 |
Disposable Valve Sets |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K192133 |
08/07/2019 |
Zimmer Biomet Universal Navigation System |
Zimmer Biomet Spine, Inc. |
Alex Pawlowski |
| K192236 |
08/19/2019 |
Fitmore Hip Stem |
Zimmer GmbH |
Roberto Tommasini |
| K192217 |
08/15/2019 |
NCB Plating System Distal Femur and Proximal Tibia |
Zimmer GmbH |
Annemie Rehor Kausch |
| K192312 |
08/26/2019 |
Zimmer Natural Nail System Cephalomedullary Nails |
Zimmer GmbH |
Annemie Rehor Kausch |
| K192194 |
08/13/2019 |
TotalShield II Surgical Helmet System |
Zimmer Surgical, Inc |
Abigail Miller |
| K192189 |
08/13/2019 |
Avenir Complete Hip System, Size 0 Coxa Vara |
Zimmer, Inc. |
Rebecca D Noftz |
