| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K182784 |
01/18/2019 |
MUTYH-Associated Polyposis (MAP) |
23andMe, Inc. |
Sarah Rys |
| K190190 |
11/01/2019 |
WV1 Endoscope |
270Surgical Ltd |
Avi Levy |
| K192937 |
11/16/2019 |
3M Comply Hydrogen Peroxide Chemical Indicator |
3M Company |
Mary Fretland |
| K191236 |
11/22/2019 |
3MÖ AttestÖ Steam Chemical Integrators |
3M Company |
Mary Fretland |
| K192992 |
11/05/2019 |
Suglue 3 |
3M Deutschland GMBH |
Desi W. Soegiarto |
| K183476 |
01/02/2019 |
3M Filtek Universal Restorative |
3M ESPE Dental Products |
Lam Duong |
| K191911 |
11/27/2019 |
3Shape Splint Design |
3Shape A/S |
Shreyosi Chakraborty |
| K190119 |
11/01/2019 |
Foryou NPWT Dressing Kit |
4L Health Co., Ltd. |
Jackie Jian |
| K192140 |
11/05/2019 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K192945 |
11/27/2019 |
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application |
7D Surgical Inc. |
Daniel Zisind |
| K192019 |
11/08/2019 |
Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 |
Abbott Medical |
Richard DeMello |
| K192769 |
11/18/2019 |
Impella CP Introducer |
Abiomed, Inc. |
Robert Stewart |
| K193041 |
11/22/2019 |
Hemochron Signature Elite |
Accriva Diagnostics, Inc. |
Brian James |
| K191734 |
11/22/2019 |
MatriStem UBM Pericardial Patch |
Acell, Inc. |
Michelle Huettner |
| K191047 |
11/05/2019 |
ADI TiDAL Osteotomy Wedge |
Additive Device, Inc. (ADI) d/b/a restor3d |
Nathan Evans |
| K182477 |
01/28/2019 |
Cervical Spacer |
Additive Implants, LLC |
Jeff Horn |
| K183011 |
01/10/2019 |
Additive Orthopaedics Patient Specific 3D Locking Lattice Plates |
Additive Orthopaedics |
Gregory Kowalczyk |
| K181887 |
01/22/2019 |
AMD Anti-Fog Solution |
Advanced Medical Design Co., Ltd |
Silvia Yeh |
| K182527 |
01/19/2019 |
ELAN 4 Tools |
Aesculap, Inc. |
Kathy A. Racosky |
| K192266 |
11/21/2019 |
M. Blue Adjustable Shunt System |
Aesculap, Inc. |
Kathy A Racosky |
| K182782 |
01/18/2019 |
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric |
Alcon Laboratories, Inc. |
Martina Heim |
| K191650 |
11/01/2019 |
LEGION System |
Alcon Research, LLC |
Nickerson Hill |
| K180435 |
01/03/2019 |
Arm Blood Pressure Monitor |
Alicn Medical (Shenzhen), Inc |
Meisong Fang |
| K190522 |
11/14/2019 |
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI an |
Allwin Medical Devices, Inc. |
Digish Mehta |
| K190590 |
11/25/2019 |
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) |
Allwin Medical Devices, Inc. |
Digish Mehta |
| K182594 |
01/24/2019 |
E-CUBE i7 |
Alpinion Medical Systems Co., Ltd. |
Boyeon Cho |
| K182312 |
01/24/2019 |
Zyppah Anti-Snoring Device |
Always More Marketing |
Jonathan Greenburg |
| K180199 |
01/04/2019 |
BIO-C TEMP |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto de Oliveira |
| K191292 |
11/05/2019 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Anhui Powerguard Technology Co.,Ltd |
Nike Dai |
| K190998 |
11/08/2019 |
BA Pit & Fissure Sealant |
Apex Dental Materials, Inc. |
Scott Lamerand |
| K190331 |
11/22/2019 |
Applied Medical Laparoscopic Linear Cutter |
Applied Medical Resources Corporation |
Aditi Iyengar |
| K182409 |
01/11/2019 |
Applied Tissue Technologies PWDÖ Platform Wound Dressing |
Applied Tissue Technologies LLC |
Michael Broomhead |
| K180570 |
01/14/2019 |
Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) |
Argentum Medical, LLC |
Paul Boentges |
| K192238 |
11/12/2019 |
AC3 Series Intra-Aortic Balloon Pump (IABP) |
Arrow International, Teleflex |
Deb Fleetham |
| K191651 |
11/06/2019 |
Arthrex Nano SwiveLock Suture Anchor |
Arthrex Inc. |
Rebecca R. Homan |
| K191426 |
11/26/2019 |
FiberTak Button |
Arthrex Inc. |
Ivette Galmez |
| K183346 |
01/24/2019 |
FLOW 90 Wand |
Arthrocare Corporation |
Shruthi Bhat |
| K192782 |
11/29/2019 |
ASAHI CROSSWALK Peripheral Support Catheter |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawuhara |
| K183070 |
01/29/2019 |
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K191464 |
11/21/2019 |
Asahi PTCA Guide Wire Asahi SION Series |
Asahi Intecc Co., LTD. |
Yasuyuki Kawahara |
| K191286 |
11/08/2019 |
CONTOUR« NEXT Blood Glucose Monitoring System, CONTOUR« NEXT USB Blood Glucose Monitoring System, CONTOUR« NEXT ONE Blood Glucose Monitoring System, CONTOUR« NEXT EZ Blood Glucose Monitoring System, CONTOUR« NEXT LINK Wireless Blood Glucose Monitoring Sys |
Ascensia Diabetes Care |
Stacie Geffner-Atiya |
| K182982 |
01/04/2019 |
BridalVeil Navigated Instruments |
Astura Medical |
Parker Kelch |
| K192125 |
11/04/2019 |
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen |
AtriCure, Inc |
Johnathon McElwee |
| K190816 |
11/19/2019 |
Vial Adapter ╪20 mm , Vial Adapter ╪13 mm |
Avenir Performance Europeenne Medical (APEM) |
Fatoumata Dao |
| K183615 |
01/25/2019 |
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle |
Avenu Medical, Inc. |
Dave Campbell |
| K183025 |
01/28/2019 |
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component |
b-One Ortho Corp. |
Allison Gecik |
| K190855 |
11/01/2019 |
BD Acute Central Line |
Bard Access Systems, Inc. (Bard has joined BD) |
Sean J. Loring |
| K192948 |
11/07/2019 |
EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G |
Bard Peripheral Vascular, Inc. |
Meghan McKelvey |
| K181864 |
01/02/2019 |
Polaris RF Ablation System |
Baylis Medical Company Inc. |
May Tsai |
| K182651 |
01/16/2019 |
HbA1c Advanced |
Beckman Coulter Ireland Inc. |
Catriona Hourigan |
| K192271 |
11/26/2019 |
Access PCT, Access PCT Calibrators |
Beckman Coulter, Inc. |
Jennifer Bennett |
| K192355 |
11/14/2019 |
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) |
Beckman Coulter, Inc. |
Elaine Duncan |
| K182692 |
01/08/2019 |
BD MAX CTGCTV2, BD MAX System |
Becton, Dickinson and Company |
Katie Edwards |
| K192519 |
11/27/2019 |
Multi-modality workstation |
Beijing Superlaser Technology Co., Ltd. |
Shi Shuang |
| K191304 |
11/04/2019 |
EthanZir Zirconia |
Besorah Dental Solutions NZ Limited |
Jobin Jose |
| K181737 |
01/02/2019 |
Raycell MK1 |
Best Theratronics Limited |
Mojgan Soleimani |
| K182193 |
01/22/2019 |
S-Line |
BIO CETEC CO., LTD. |
Hee See JIN |
| K182919 |
01/25/2019 |
SI-Restore« Sacroiliac Joint Fixation System |
Biofusion Medical |
Rylan Reed |
| K192738 |
11/26/2019 |
ETEST Delafloxacin (DFX) (0.002-32 ╡g/mL) |
BioMerieux SA |
Sophie Quiblier |
| K183031 |
01/11/2019 |
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ╡g/mL) |
bioMerieux SA |
Marine Taravant |
| K183553 |
01/22/2019 |
Compress and Mini Compress Anti-Rotation Spindles |
Biomet, Inc |
Michael McBurney |
| K182463 |
11/06/2019 |
Silicone Foley Catheter |
Biosensors International Pte Ltd |
Lor Yen Yin |
| K192480 |
11/21/2019 |
Torpedo Gelatin Foam |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K192996 |
11/21/2019 |
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
Biotronik, Inc |
Jon Brumbaugh |
| K182917 |
11/18/2019 |
FluoroCal |
Bisco, Inc |
Ryan Hobson |
| K181302 |
01/17/2019 |
Bodycad Unicompartmental Knee System |
Bodycad Laboratories Inc. |
Marc Chaunet |
| K192403 |
11/08/2019 |
VK100 Percutaneous Vertebral Augmentation System |
BONWRx Ltd |
Ralph W. Carmichael |
| K192438 |
11/27/2019 |
Rhythmia HDxTM Mapping System |
Boston Scientific Corporation |
Lee Margolin |
| K183636 |
01/22/2019 |
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller |
Boston Scientific Corporation |
Carter Navarro |
| K183175 |
01/04/2019 |
BostonSight Scleral |
BostonSight |
Gene Guselli |
| K180355 |
01/10/2019 |
Advocate Non-Contact Infrared Thermometer |
BroadMaster Biotech, Corp. |
Ke-Min Jen |
| K182363 |
01/24/2019 |
BTL-703 |
BTL Industries, Inc. |
David Chmel |
| K183200 |
01/09/2019 |
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses |
C&E GP Specialist, Inc. |
Steve Wagner |
| K190760 |
11/23/2019 |
Cadwell Bolt Software |
Cadwell Industries, Inc. |
Emily Whitehead |
| K192632 |
11/07/2019 |
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless |
Canon, Inc. |
Yamazaki Tatsuya |
| K190923 |
11/07/2019 |
Salem Sump Dual Lumen Stomach Tube with ENFit Connection |
Cardinal Health |
Alexis Erazo |
| K183474 |
01/16/2019 |
Carestream DRX-1 System with DRX Core Detectors |
Carestream Health, Inc. |
Victoria Wheeler |
| K190330 |
11/04/2019 |
DRX-Evolution/Plus with Dual Energy |
Carestream Health, Inc. |
Carolyn Wagner |
| K180229 |
01/11/2019 |
RESCAN 700, CALLISTO eye |
Carl Zeiss Meditec AG |
Christian Muenster |
| K181444 |
01/10/2019 |
CLARUS |
Carl Zeiss Meditec, Inc. |
Saurabh Jamkhindikar |
| K182500 |
01/11/2019 |
Catalyst CSR Press-Fit Humeral Components |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K182010 |
01/17/2019 |
ProgenaMatrix |
Cell Constructs I, LLC |
Elizabeth O'Keeffe |
| K192871 |
11/07/2019 |
B. anthracis Real-time PCR Assay |
Centers for Disease Control and Prevention |
Yon Yu |
| K192113 |
11/15/2019 |
DRSplus |
CenterVue SpA |
Roberto Gabriotti |
| K183214 |
01/03/2019 |
Raven Lumbar Plate System |
Choice Spine, LP |
Kim Finch |
| K182721 |
01/08/2019 |
Choice Spine Navigation System |
Choice Spine, LP. |
Kim Finch |
| K183666 |
11/14/2019 |
EBA One Nailing System |
CITIEFFE S.r.l. |
Stefano Pullega |
| K181540 |
01/16/2019 |
Estremo Citieffe Nailing System |
CITIEFFE S.r.L. |
Stefano Pullega |
| K192168 |
11/04/2019 |
Idys ALIF ZP 3DTi |
CLARIANCE, SAS |
Fadwa Bahr |
| K190868 |
11/05/2019 |
Cleerly Labs |
Cleerly Inc |
Kimberly Elmore |
| K191921 |
11/15/2019 |
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments |
Cochlear Americas |
Chinda Hemmavanh |
| K191237 |
11/08/2019 |
CERENOVUS Large Bore Catheter |
Codman & Shurtleff, Inc. |
Kirsten Franco |
| K182202 |
01/11/2019 |
SLEEPAPP |
Comfort Acrylics, Inc. |
Richard W. Moore |
| K192198 |
11/06/2019 |
Conformis Hip System |
Conformis, Inc. |
Paul Smolenski |
| K182621 |
01/04/2019 |
CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver |
ConMed Corporation |
Diana L. Nader-Martone |
| K182955 |
01/22/2019 |
EZStart Interference Screw |
ConMed Corporation |
Jeremy Walter |
| K182439 |
01/08/2019 |
TruShot with Y-Knot Shallow All-Suture Anchor |
ConMed Corporation |
Diana L. Nader-Martone |
| K180837 |
01/10/2019 |
CONTEC Oxygen Concentrator |
Contec Medical System Co., Ltd. |
Xueyong Li |
| K181097 |
01/18/2019 |
Cook Cystostomy Catheter Set |
Cook Incorporated |
Danlu Chen |
| K183467 |
01/11/2019 |
Roadrunner Extra Support Wire Guide |
Cook Incorporated |
Daniel J. Corbin |
| DEN180062 |
11/20/2019 |
EchoTip Insight Portosystemic Pressure Gradient Measuring System |
Cook Ireland Ltd. |
Jane Kennedy |
| K183020 |
01/31/2019 |
Endosee System |
CooperSurgical, Inc. |
Roaida Johnson |
| K190143 |
11/04/2019 |
LARS AC Band Device |
Corin USA |
Lucinda Gerber |
| K181580 |
01/29/2019 |
Cortex CAD/CAM Abutments |
Cortex Dental Implants Industries Ltd. |
Ronit Polack |
| K181086 |
01/09/2019 |
Cortical Fixation Systems |
Cousin Biotech S.A.S. |
Mathilde Collet |
| K182868 |
01/08/2019 |
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor |
Covidien llc |
Samir Ibrahim |
| K182199 |
01/02/2019 |
NFC-700 non-mydriatic auto fundus camera |
Crystalvue Medical Corporation |
Oliver Lin |
| K182741 |
01/03/2019 |
SculpSure |
Cynosure |
Amy Tannenbaum |
| K192643 |
11/19/2019 |
Dannik Laparoscopic Suction Irrigation System |
Dannik |
Olga Haberlad |
| K191361 |
11/07/2019 |
DemeDIOX Barbed Absorbable Surgical Suture |
DemeTECH Corporation |
Tracy Chadwrick |
| K191634 |
11/04/2019 |
Scan Abutments and Comfort Caps |
Dentium Co., Ltd. |
Byung-sun Kim |
| K183465 |
11/02/2019 |
Allcem, Allcem Core |
Dentscare LTDA |
Roberta Uyara |
| K190977 |
11/22/2019 |
Navina Smart System, Navina Classic System |
Dentsply Sirona |
Karl Nittinger |
| K191865 |
11/20/2019 |
SmartLite Pro Modular LED Curing Light |
Dentsply Sirona |
Karl Nittinger |
| K190344 |
11/01/2019 |
DePuy Corail AMT Hip Prosthesis |
DePuy (Ireland) |
Kathy Harris |
| K192946 |
11/26/2019 |
DePuy Corail AMT Hip Prosthesis |
DePuy Orthopaedics, Inc. |
Kathy Harris |
| K182301 |
11/08/2019 |
PFC SIGMA Knee System |
DePuy Orthopaedics, Inc. |
Kathy Harris |
| K192919 |
11/26/2019 |
Pinnacle Duofix HA Acetabular Cup Prosthesis |
DePuy Orthopaedics, Inc. |
Kathy Harris |
| K192376 |
11/26/2019 |
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K190544 |
11/01/2019 |
XIHPOSÖ ZFUZEÖ Interbody Fusion System |
DiFusion Technologies |
Derrick Johns |
| K190955 |
11/27/2019 |
Hypotension Decision Assist |
Directed Systems Ltd |
Mark S. Leaning |
| K192573 |
11/19/2019 |
Dolphin Medical Imaging USB Ultrasound System |
Dolphin Medical Imaging, LLC |
Brian S. Heaney |
| K190312 |
11/15/2019 |
Dornier Ureteral Stent |
Dornier MedTech America Inc. |
John Hoffer |
| K180410 |
01/16/2019 |
Dosis SAM |
Dosis, Inc. |
Divya Chhabra |
| K180779 |
01/17/2019 |
Savina 300 |
Dragerwerk AG & CO. KGaA |
Dr. Bettina Mobius |
| K190571 |
11/07/2019 |
StoneBite and StoneBite scan |
Dreve Dentamid GmbH |
Reiner Altmann |
| K193017 |
11/22/2019 |
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP |
DRTECH Corporation |
Shin Dongwook |
| K193031 |
11/22/2019 |
EXPD 4343P, EXPD 3643P |
DRTECH Corporation |
Dongwook Shin |
| K182480 |
01/25/2019 |
Earlens Contact Hearing Aid |
Earlens Corporation |
Judith A. Brimacombe |
| K192791 |
11/27/2019 |
Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Stella Guo |
| K192242 |
11/22/2019 |
Synergy Platform, Synergy, Infinity, VersaHD |
Elekta Limited |
Irina Proutski |
| K191564 |
11/07/2019 |
Progenikine Concentrating System 25 mL System |
Emcyte Corporation |
Patrick Pennie |
| K190439 |
11/21/2019 |
EngageÖ Partial Knee System |
Engage UNI, LLC |
Nicholas Slater |
| K192661 |
11/10/2019 |
LATERA Absorbable Nasal Implant System |
Entellus Medical, Inc. (Aka Stryker ENT) |
Karen E. Peterson |
| K192079 |
11/27/2019 |
EOSedge |
EOS imaging |
Bernard Ismael |
| K190189 |
11/01/2019 |
MDT2 BLE Self-Monitoring Blood Glucose System |
EPS Bio Technology Corp. |
Cynthia Hung |
| K183685 |
01/22/2019 |
O-Scan |
Esaote S.p.A |
Massimo Polignano |
| K192157 |
11/22/2019 |
6450 Ultrasound system |
Esaote, S.p.A. |
Piet DeJong |
| K182873 |
01/10/2019 |
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices |
Ethicon, Inc. |
Ariell Joiner |
| K192842 |
11/15/2019 |
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High |
Eurotrol B.V. |
Elisanne Biemans |
| K182478 |
01/15/2019 |
Whistler Modular Pedicle Screw System |
Evolution Spine, LLC |
Douglas Davis |
| K192592 |
11/21/2019 |
Axis Plating System |
Extremity Medical, LLC. |
Brian Smekal |
| K191673 |
11/27/2019 |
Upper Arm Blood Pressure Monitor |
Famidoc Technology Company Limited |
Leon Cao |
| K183004 |
01/28/2019 |
WEGO-PGA RAPID |
Foosin Medical Supplies Inc., Ltd |
Lei Tang |
| K183001 |
01/28/2019 |
WEGO-PGLA RAPID |
Foosin Medical Supplies Inc., Ltd |
Lei Tang |
| K191987 |
11/27/2019 |
Orapeutic |
Forward Science |
Brian Pikkula |
| K192150 |
11/13/2019 |
AMICUS Separator System |
Fresenius Kabi AG |
Aunica Jones |
| K182367 |
01/10/2019 |
DIASAFEplusUS |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K192932 |
11/12/2019 |
FDR D-EVO III flat panel detector system |
FUJIFILM Corporation |
Randy Vader |
| K192440 |
11/01/2019 |
FDR SE Lite |
Fujifilm Corporation |
Randy Vader |
| K192664 |
11/20/2019 |
FUJIFILM Endoscope Model EC-760Z-V/L |
FUJIFILM Corporation |
Randy Vader |
| K192323 |
11/18/2019 |
PolyLock Small Bone Plating System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K181282 |
01/09/2019 |
G3A 40 Bone Cement |
G21 S.r.l |
Filippo Foroni |
| K192026 |
11/26/2019 |
Peridot Intervertebral body fusion System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K192260 |
11/22/2019 |
everX Flow |
GC America Inc. |
Mark Heiss |
| K182951 |
01/18/2019 |
Pristina Serena 3D |
GE Healthcare |
Nicole Landreville |
| K183362 |
01/28/2019 |
Venue GO |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K183231 |
01/18/2019 |
SIGNA Premier |
GE Medical Systems, LLC |
Brian R. Zielski |
| K192819 |
11/08/2019 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Kenny M Bello |
| K182000 |
01/29/2019 |
AQrate Robotic Assistance System |
Globus Medical Inc. |
Kelly J. Baker |
| K192269 |
11/19/2019 |
TwinScan 808/755 Laser System |
GME German Medical Engineering GmbH |
Stefan Schulze |
| K182672 |
11/15/2019 |
ROSA Bracket |
GNI Co., LTD |
Duk Soo Kim |
| K190872 |
11/07/2019 |
BioGenesis Fertility Lubricant |
Good Clean Love, Inc. |
Wendy Strgar |
| K192915 |
11/13/2019 |
GMA 2.0 Pedicle Screw System |
Grafton Medical Alliance |
James Henry |
| K182212 |
01/11/2019 |
Geo Staple System |
Gramercy Extremity Orthopedics, LLC |
Michael P. Simpson |
| K182078 |
01/25/2019 |
MiniCollect K2E K2EDTA Tubes |
Greiner Bio-One NA Inc. |
Manfred Abel |
| K191570 |
11/13/2019 |
Infrared Thermometer Model MD-H30 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K192468 |
11/27/2019 |
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, O |
Hangzhou Bever Medical Devices Co., Ltd. |
Allyson Zhou |
| K183298 |
01/18/2019 |
HardyDisk AST Omadacycline 30╡g (OMC30) |
Hardy Diagnostics |
Anna Klavins |
| K192232 |
11/08/2019 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) |
Hartalega NGC Sdn. Bhd. |
Kuan Mun Leong |
| K191502 |
11/26/2019 |
Heraeus Peripheral Guidewire |
Heraeus Medical Components, LLC |
Chelsea Pioske |
| K191016 |
11/01/2019 |
COPAL exchange G Hip and Knee Spacers |
Heraeus Medical GmbH |
Ljuba Jitaau |
| K191110 |
11/14/2019 |
HeraBEATÖ US |
HeraMED Ltd. |
Dganit Litinsky |
| K180387 |
01/10/2019 |
Infrared Ear Thermometer |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K191201 |
11/15/2019 |
EM SA Implant System |
Hiossen, Inc. |
Peter Lee |
| K183456 |
01/28/2019 |
Aloka Arietta 850 |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K192264 |
11/08/2019 |
HIVOX Spopad EMS SP-911, SP-921 |
Hivox Biotek Inc. |
Marx Lee |
| DEN180047 |
01/23/2019 |
Aptima Mycoplasma genitalium Assay |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K182727 |
01/10/2019 |
Trident HD Specimen Radiography System |
Hologic, Inc. |
Meghan Wakeford |
| K191477 |
11/13/2019 |
AEON-C Stand Alone System |
Huvexel Co., Ltd |
Sung Kyu Hur |
| K190268 |
11/06/2019 |
Hydrofera Blue READY - Border |
Hydrofera, LLC |
Sean Anderson |
| K182453 |
01/11/2019 |
ICOONE h (also referred to as ICOONE LASER and ICOONE ûh LASER) |
I-TECH INDUSTRIES SRL |
Paolo Abbreviato |
| K192109 |
11/05/2019 |
KOALA |
IB Lab GmbH |
Richard Ljuhar |
| K180780 |
01/25/2019 |
microINR System |
iLine Microsystems S.L. |
Alberto Molinero |
| K190397 |
11/15/2019 |
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA |
Immunalysis Corporation |
Yang Yang |
| K181135 |
01/24/2019 |
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K190529 |
11/25/2019 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K181071 |
01/16/2019 |
SIRA RFA Electrosurgical Device |
Innoblative Designs, Inc. |
Tyler Wanke |
| K192105 |
11/29/2019 |
Innonix Antiviral Child's Face Mask |
Innonix Technologies Limited |
Tommy Lui |
| K192049 |
11/08/2019 |
Oryx Cervical Plate System |
Innovasis, Inc. |
Marshall McCarty |
| K181126 |
01/18/2019 |
Reprocessed Visions PV .035 Digital IVUS Catheter |
Innovative Health, LLC |
Amanda Babcock |
| K192843 |
11/22/2019 |
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream |
Innovita (Tangshan) Biological Technology Co., Ltd |
Leo Lee |
| K180477 |
01/04/2019 |
Straumann PURE Ceramic Implant System |
Institut Straumann AG |
Pierre-Yves Calinon |
| K182630 |
01/08/2019 |
Omnipod Insulin Management System, Omnipod DASH Insulin Management System |
Insulet Corporation |
Julie Perkins |
| K183406 |
01/11/2019 |
CereLink ICP Monitor, CereLink ICP Extension Cable |
Integra LifeSciences Corp. |
Megan Palumbo |
| K183581 |
01/20/2019 |
Codman Disposable Perforators |
Integra LifeSciences Corp. |
Jocelyn Raposo |
| K182114 |
01/07/2019 |
FlareHawk Interbody Fusion System |
Integrity Implants Inc |
Lauren Kamer |
| K190512 |
11/22/2019 |
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare |
Intelligent Endoscopy |
Melissa Clark |
| K182956 |
01/18/2019 |
Puffin Lite Infant Resuscitation System |
International Biomedical |
Amy Pieper |
| K181387 |
01/23/2019 |
Pre-Formed Penile Silicone Block |
International Medical Devices, Inc. |
James Elist |
| K182545 |
01/11/2019 |
Tamper Evident Cap with Male Luer Lock |
International Medical Industries, Inc. |
Kathleen Lavender |
| K181127 |
01/03/2019 |
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control |
Interscope, Inc. |
Jeffery Ryan |
| K183224 |
01/18/2019 |
SureForm 45, SureForm 45 Reloads |
Intuitive Surgical |
Nadine Nasr |
| K191280 |
11/14/2019 |
E-100 Electrosurgical Generator, SynchroSeal |
Intuitive Surgical, Inc. |
Melissa Gonzalez |
| K192367 |
11/26/2019 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
Jennifer Siu |
| K183713 |
01/09/2019 |
Wireless Digital Flat Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K183422 |
01/09/2019 |
Wireless Digital Flat Panel Detector |
iRay Technology Taicang Ltd. |
Meng Li |
| K192289 |
11/15/2019 |
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit |
IRRAS USA, Ltd. |
Vinny Podichetty |
| K192417 |
11/26/2019 |
ARIX Cannulated Screw System |
Jeil Medical Corporation |
Sejin Ryu |
| K191972 |
11/12/2019 |
ARIX Wrist System |
Jeil Medical Corporation |
Ahhyeon Woo |
| K181106 |
01/16/2019 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
JiangSu DongXin Medical Technology Co., Ltd |
Deng Yujie |
| K190958 |
11/09/2019 |
Neodent Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K182620 |
01/18/2019 |
MRI Compatibility for Existing Neodent Implant System |
JJGC Industria e Comercio de Materiais Dentarios SA |
Julianne Lachechem |
| K182732 |
11/18/2019 |
JTL-250-01 |
Jointechlabs, Inc. |
Thomas Lawson |
| K183393 |
11/18/2019 |
Digital Thermometer |
Joytech Healthcare Co.,Ltd |
Ren Yunhua |
| K192329 |
11/25/2019 |
Blue Latex Examination Powder Free Gloves |
JR Engineering & Medical Technologies (M) SDN.BHD. |
Ganesan Surbramaniam |
| K192911 |
11/14/2019 |
Brainlab Compatible K2M Navigation Instruments |
K2M, Inc. |
Oonagh Lahiff |
| K182210 |
01/07/2019 |
TiWAVE-L Porous Titanium Lumbar Cage |
Kalitec Medical, LLC |
Scott Winn |
| K182712 |
11/23/2019 |
DEXIS CariVu 3-in-1 by KaVo |
Kaltenbach & Voigt GmbH |
Stefan Trampler |
| K183264 |
01/18/2019 |
Flex-THOR scope |
KARL STORZ Endoscopy-America, Inc. |
Nozomi Yagi |
| K190697 |
11/22/2019 |
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) |
KCI USA, Inc. |
Patricia Lopez |
| K191527 |
11/08/2019 |
Visalys CemCore, Visalys Cem Core Try In Paste |
Kettenbach GmbH & Co. KG |
Katja Simon |
| K183598 |
11/15/2019 |
KeyPrint KeySplint Soft |
Keystone Industries |
Negar Movahed |
| K191028 |
11/22/2019 |
KLS Martin Individual Patient Solutions |
KLS-Martin L.P. |
Jennifer Damato |
| K181099 |
01/18/2019 |
Bright Guard |
Koncept Innovators, LLC. |
Sylvan Newby |
| K191754 |
11/22/2019 |
Hair Growth System |
Kunshan Bella Optical technology Co., Ltd. |
Wu Xuefeng |
| K191980 |
11/18/2019 |
CLEARFIL MAJESTY ES Flow |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K181895 |
01/18/2019 |
Kurin PIV Blood Collection Set with High Pressure |
Kurin, Inc |
Bob Rogers |
| K183392 |
01/04/2019 |
PicoLO Nd:YAG Picosecond Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K183671 |
01/22/2019 |
LG PRA.L DERMA LED MASK |
LG Electronics, Inc. |
Jooyong Kim |
| K180767 |
01/22/2019 |
FEMON Banana Thermometer |
Life Science Technology Inc. |
Jaewoo Jun |
| K190721 |
11/14/2019 |
LongBow Ti |
Life Spine Inc. |
Angela Batker |
| K181775 |
01/28/2019 |
Quantum Blood and IV Fluid Infusion Warmer |
Life Warmer, Inc. |
John Pettini |
| K190911 |
11/26/2019 |
Physica KR Liner and SMR Reverse Humeral Liner |
LimaCorporate |
Roberto Gabetta |
| K191746 |
11/22/2019 |
SMR TT Augmented Glenoid System |
Limacorporate S.p.A |
Michela Zanotto |
| K191622 |
11/01/2019 |
Delta Multihole TT Pro Acetabular System |
Limacorporate S.p.A. |
Roberto Gabetta |
| K183042 |
01/25/2019 |
SMR Lateralized Connectors with screws |
Limacorporate S.p.A. |
Roberto Gabetta |
| K192299 |
11/21/2019 |
LZI Cotinine II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K183140 |
01/11/2019 |
MTS Tetracycline 0.016 - 256 ug/mL |
Liofilchem s.r.l. |
Fabio Brocco |
| K191161 |
11/12/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K191160 |
11/04/2019 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K192331 |
11/12/2019 |
LaseMD LEO Laser System |
Lutronic Global |
James Childs |
| K183616 |
01/10/2019 |
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
Inae Kim |
| K181956 |
01/23/2019 |
Masimo MightySat Rx Fingertip Pulse Oximeter |
Masimo Corporation |
Kelly Nguyen |
| K182986 |
01/30/2019 |
Boston Keratoprosthesis, Type I Lucia |
Massachusetts Eye and Ear Infirmary d/b/a Boston |
James Chodosh |
| K182574 |
01/22/2019 |
Freedom Ultra-Congruent CR Tibial Liner |
Maxx Orthopedics, Inc. |
Priscilla Herpai |
| K192126 |
11/22/2019 |
AMIStem-P Short Neck |
Medacta International SA |
Stefano Baj |
| K182837 |
01/22/2019 |
M.U.S.T. Mini Extension |
Medacta International SA |
Stefano Baj |
| K183029 |
01/30/2019 |
MOTO Partial Knee System |
Medacta International SA |
Stefano Baj |
| K192297 |
11/08/2019 |
APTUS Wrist Arthrodesis Plates |
Medartis AG |
Andrea Kiefer-Schweizer |
| K180564 |
01/07/2019 |
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases |
Medentika GmbH |
Gerhard Polzer |
| K192891 |
11/07/2019 |
Laparoscope Lens Shield Device (LENS) |
Medeon Biodesign, Inc |
Tsung-Yu Hsieh |
| K183631 |
01/25/2019 |
medi pneumatic compression system (pcs) û brio (Model 651) |
Medi USA, LP |
Glenn Anderson |
| K191026 |
11/07/2019 |
MEDIP PRO |
MEDICALIP Co., Ltd |
Yoon Bo Chung |
| K180902 |
01/11/2019 |
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly |
MediPines Corporation |
Steve Lee |
| K192281 |
11/20/2019 |
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 |
| K192508 |
11/22/2019 |
Medsynapse Ris Pacs & Medsynapse VNA |
Medsynaptic Private Ltd |
Ashish Dhawad |
| K191851 |
11/25/2019 |
VS3-IR |
Medtronic |
Alex Chanin |
| K191597 |
11/01/2019 |
Stealth Autoguide System, Midas Rex Legend Depth Stop System |
Medtronic Navigation, Inc. |
Jason Woehrle |
| K182928 |
01/11/2019 |
CD HorizonÖ Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Raphael McInnis |
| K192336 |
11/22/2019 |
Navigated Anterolateral Disc Prep Instruments |
Medtronic Sofamor Danek USA, INC. |
Parwinder Singh |
| K182497 |
01/15/2019 |
OsteoCool RF Ablation System |
Medtronic Sofamor Danek USA, Inc. |
Laveeda Leflore |
| K183510 |
01/16/2019 |
T2 STRATOSPHERE Expandable Corpectomy System |
Medtronic Sofamor Danek, USA Inc. |
Elizabeth Hamilton |
| K192347 |
11/14/2019 |
ST Internal Implant System |
Megagen Implant Co. Ltd |
You Jung Kim |
| K182538 |
01/16/2019 |
Merit RadialFlo Arterial Catheter |
Merit Medical Singapore Pte. Ltd. |
Xing Ting Seow |
| K192907 |
11/26/2019 |
Advocate PTA Catheter |
Merit Medical Systems Inc. |
Mark Mullaney |
| K183022 |
01/29/2019 |
Solitaire 4 Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Helen Chow |
| K192625 |
11/21/2019 |
PG Pro Microcatheter |
MicroVention, Inc., A Terumo Group Company |
Ganesh Balachandar |
| K182929 |
11/06/2019 |
BIO-RAY A-1 Anchor Screw System |
Microware Precision Co., Ltd. |
Harrison Du |
| K190334 |
11/01/2019 |
MIMOSA Imager |
MIMOSA Diagnostics Inc |
Yuan Fang |
| K182970 |
01/22/2019 |
EUROPAÖ Pedicle Screw System |
MiRus, LLC |
Jordan Bauman |
| K182228 |
01/28/2019 |
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K182297 |
01/24/2019 |
Surveyor S2 |
Mortara Instrument Inc |
Marco Manduchi |
| K191701 |
11/15/2019 |
Arcus Head Fixation Frame |
MRI Interventions, Inc. |
Pete Piferi |
| K191278 |
11/19/2019 |
RSI-MRI+ |
MultiModal Imaging Services Corporation (dba HealthLytix) |
Stephen Kosnosky |
| K183497 |
01/15/2019 |
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor |
Nanjing Jusha Display Technology Co., Ltd. |
Zilong Liang |
| K190661 |
11/09/2019 |
Omics Core |
NantHealth, Inc. |
Aleece Nolasco |
| K182766 |
01/03/2019 |
Cufitec Surgical Mask |
NBC Meshtec Inc. |
Tomokazu Nagao |
| K181048 |
01/29/2019 |
Neo Cage System TM |
Neo Medical S.A. |
Jonas Larsson |
| K192186 |
11/29/2019 |
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph |
Neurolign USA, LLC |
Aura Kullmann |
| K192764 |
11/26/2019 |
NeuroOne Cortical Electrode |
NeuroOne, Inc. |
Debra Kridner |
| K192248 |
11/25/2019 |
CortinaÖ [MAX] Lumbar Cage System |
NeuroStructures, Inc. |
Moti Altarac |
| K182227 |
01/17/2019 |
Esprit Nova |
Neurozone MSH Incorporated |
Daniel Ramirez Rodriguez |
| K192153 |
11/07/2019 |
Portux CAD/CAM Disc |
New Stetic S.A. |
Juan David Jaramillo G. |
| K182518 |
01/18/2019 |
AHMED ClearPath Glaucoma Drainage Device |
New World Medical, Inc. |
Mukesh Sabarad |
| K192045 |
11/15/2019 |
Ophthalmic Yag Laser System YC-200 |
Nidek Co., Ltd. |
Tsutomu Sunada |
| K190494 |
11/25/2019 |
Infant Incubator |
Ningbo David Medical Device Co.,Ltd |
Lin Dingyu |
| K180984 |
01/03/2019 |
Maxcon Sharps Container |
Ningbo Maxcon Medical Technology Co., Ltd. |
Yang Song |
| K180983 |
01/03/2019 |
Maxcon Two Gallon Chemotherapy Container |
Ningbo Maxcon Medical Technology Co., Ltd. |
Yang Song |
| K191032 |
11/27/2019 |
fMRI Hardware System |
NordicNeurolab AS |
Chandana Gurung Bhandari |
| K182907 |
01/23/2019 |
SPY Elite Intraoperative Perfusion Assessment System |
Novadaq Technologies ULC. (now a part of Stryker) |
Agatha Szeliga |
| K192174 |
11/15/2019 |
SPY Portable Handheld Imaging (SPY-PHI) System |
Novadaq Technologies ULC. (now a part of Stryker) |
Agatha Szeliga |
| K192469 |
11/13/2019 |
Nox Sleep System |
Nox Medical |
Kolburn E Ottosdottir |
| K181917 |
01/11/2019 |
MTA2.3 MATERIALS |
NuSmile, LTD. |
Alafiz Prasla |
| K192181 |
11/07/2019 |
PRECICE Plating System |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K191974 |
11/03/2019 |
NuVasive AttraX Putty |
NuVasive, Incorporated |
Jessica LeBlanc |
| K192582 |
11/13/2019 |
NuVasive CoRoent Small Interlock System |
NuVasive, Incorporated |
Jessica LeBlanc |
| K191230 |
11/08/2019 |
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves |
O & M Halyard, Inc. |
Steve Dowdlley |
| K181451 |
01/16/2019 |
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K183329 |
01/16/2019 |
Laser Hair Therapy |
OMM Imports, Inc. D/B/A Zero Gravity |
Moti Shenfarber |
| K182120 |
01/10/2019 |
Maxpower Relief |
Omron Healthcare, Inc. |
Renee Thornborough |
| K181839 |
11/21/2019 |
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray |
OraLabs, Inc. |
Gary Schlatter |
| K182327 |
01/30/2019 |
Patient Cables and Leadwires , Disposable ECG Leadwires |
Orantech Inc. |
Hsin Xiong |
| K190003 |
11/06/2019 |
Vivid Aligners |
Orthodent Laboratory, Inc. |
Michael Wright |
| K192080 |
11/05/2019 |
iASSIST Knee System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Eduardo Mendoza |
| K182964 |
01/24/2019 |
ROSA Knee System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Eric DesRosiers |
| K190608 |
11/04/2019 |
Mei Ceramic Bracket |
Orthosun Co., Ltd. |
Ju-Sung Lee |
| K192379 |
11/27/2019 |
Hi-Fatigue G Bone Cement |
OSARTIS GmbH |
Volker Stirnal |
| K181180 |
01/10/2019 |
OSSIOÖ Pin Product Family |
Ossio Ltd. |
Taly Lindner |
| K183352 |
01/02/2019 |
Optimus Neuro System |
Osteonic Co., Ltd |
Seyoung Choi |
| K190811 |
11/27/2019 |
Optimus NEURO System - Sterile Kit |
Osteonic Co., Ltd |
Choi Se Young |
| K171899 |
11/22/2019 |
Revitalair 430F |
Oxavita S.R.L. |
Eduardo Northing |
| K180228 |
01/11/2019 |
II-Type Intervertebral Spacer |
Paonan Biotech Co., Ltd. |
Vivi Tsai |
| K180230 |
01/25/2019 |
NEST Interbody System |
Paonan Biotech Co., Ltd. |
Tony Lin |
| K182307 |
01/14/2019 |
Small Bone Phantom« Intramedullary Nail System; TTC Phantom« Intramedullary Nail System |
Paragon 28, Inc |
Eric Lintula |
| K182898 |
01/14/2019 |
TenoTac Soft Tissue Fixation System |
Paragon 28, Inc |
Eric Lintula |
| K183228 |
01/25/2019 |
HammerToe Compression System |
Paragon 28, Inc. |
Eric Lintula |
| K192824 |
11/02/2019 |
Parcus Knotless AP Suture Anchors |
Parcus Medical, LLC |
Paul Vagts |
| K192964 |
11/22/2019 |
Parcus Synd-EZ SS |
Parcus Medical, LLC |
Paul Vagts |
| K180648 |
01/08/2019 |
Park Dental Research Aligners |
Park Dental Research Corporation |
Ronald A. Bulard |
| K191103 |
11/22/2019 |
Parkell Desensitizer Gel |
Parkell, Inc. |
David Mott |
| K193036 |
11/22/2019 |
C2 CryoBalloon EndoGrip |
PENTAX Medical, A Division of PENTAX of America, Inc. |
Gurvinder Singh Nanda |
| K182846 |
01/09/2019 |
PENTAX Medical EPK-3000 Video Imaging System |
PENTAX of America, Inc. |
William Goeller |
| K191282 |
11/08/2019 |
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family |
PENTAX of America, Inc. |
William Goeller |
| K192245 |
11/15/2019 |
Pentax Medical Video Duodenoscope ED34-i10T2 |
PENTAX of America, Inc. |
William Goeller |
| K190799 |
11/12/2019 |
PENTAX Medical Video Upper GI Scopes (EG Family) |
PENTAX of America, Inc. |
William Goeller |
| K181084 |
01/18/2019 |
PENTAX Video Colonoscopes (EC Family) |
PENTAX of America, Inc. |
James W. Monroe |
| K192955 |
11/20/2019 |
Penumbra LP Coil System |
Penumbra, Inc. |
Anush Puvvada |
| K190335 |
11/06/2019 |
GSP Neonatal Total Galactose kit |
PerkinElmer Inc. |
Brian Ciccariello |
| K183133 |
01/09/2019 |
MRCP+ v1.0 |
Perspectum Diagnostics Ltd |
Jaco Jacobs |
| K190710 |
11/29/2019 |
EliA SymphonyS Immunoassay |
Phadia AB |
Carina Magnusson |
| K182973 |
01/11/2019 |
DigitalDiagnost C90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K182979 |
11/19/2019 |
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K192396 |
11/26/2019 |
Streamline MIS Spinal Fixation System |
Pioneer Surgical Technology, Inc. |
Michael Mach |
| K183060 |
01/17/2019 |
CervAlignÖ Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Jaclyn Holli |
| K191976 |
11/13/2019 |
Piper GO-IO Intraosseous Infusion System |
Piper Access, LLC |
Jacob Lee |
| K190541 |
11/05/2019 |
MTS225 and MTS300 Multiple Tray Sterilization Systems |
PMBS, LLC |
Michele E. Mauzerall |
| K182675 |
01/04/2019 |
Polygon Resection Device |
Polygon Medical, Inc. |
Ronald Adams |
| K191903 |
11/22/2019 |
BruxZir GT (Gum Tissue) Color |
Prismatik Dentalcraft, Inc. |
Mythili Reguraman |
| K183165 |
01/16/2019 |
Pristine Scope |
Pristine Surgical |
Stewart B. Davis |
| K192858 |
11/05/2019 |
A1AT Genotyping Test |
Progenika Biopharma S.A., A Grifols Company |
Diego Tejedor |
| K183541 |
01/24/2019 |
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems |
Prognosys Medical Systems Private Limited |
V. Krishna Prasad |
| K182855 |
01/02/2019 |
ProKnow DS |
ProKnow LLC |
Salvadore Gerace |
| K183018 |
11/01/2019 |
VPro5 |
Propel Orthodontics LLC |
Bryce Way |
| K191959 |
11/08/2019 |
QuantX Breast MRI Biopsy Guidance Plugin |
Qlarity Imaging |
Robert Tomek |
| K182521 |
01/29/2019 |
FastPack IP Sex Hormone Binding Globulin Immunoassay |
Qualigen, Inc. |
Wajdi Abdul-Ahad |
| K182211 |
01/18/2019 |
Aurora Surgiscope System |
Rebound Therapeutics Corporation |
Jane Metcalf |
| K190797 |
11/18/2019 |
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) |
Reed Medical (Zhejiang) Co., Ltd. |
Lu Zhong Zhong |
| K181118 |
01/09/2019 |
Reliance Lumbar IBF System |
Reliance Medical Systems |
Bret M Berry |
| K192270 |
11/22/2019 |
LEva Pelvic Digital Health System |
Renovia Inc. |
Gina Prochilo-Cawston |
| K181053 |
01/04/2019 |
Care Orchestrator |
Respironics Inc. |
Ankitha Rao |
| K180951 |
01/03/2019 |
Responsive Arthroscopy Suture Anchor System |
Responsive Arthroscopy LLC |
Doug Kohrs |
| K181076 |
01/18/2019 |
Responsive Arthroscopy Wedge Push-In Suture Anchors |
Responsive Arthroscopy LLC |
Doug Kohrs |
| K191693 |
11/01/2019 |
BC-5 |
Reveallux, Corp |
Justin D Linn |
| K183468 |
01/25/2019 |
Revive Reusable Bladder Support |
Rinovum Subsidiary 2, LLC |
Shaylee Masilunas |
| K180183 |
01/24/2019 |
Ritter Dental Implant System |
Ritter Implants GmbH & Co. KG |
Wemer Schmitz |
| K181845 |
11/25/2019 |
Pivot System Sterilization case |
RP Medical, Inc. |
Jim Barley |
| K181129 |
01/31/2019 |
STRONG Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Jong Woo |
| K182892 |
11/26/2019 |
TRAUS Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Jong Woo |
| K182635 |
01/10/2019 |
Signal Catheter |
Safe Medical Design |
Raymond "Buzz" Bonneau |
| K180139 |
01/03/2019 |
Safe Secure Sterilization Pouches and Rolls |
Safe Secure Packing Co., Ltd. |
Howard Jia |
| K191488 |
11/21/2019 |
SAM IO Intraosseous Access System |
SAM« Medical Products, Inc. |
Jeff Lipps |
| K182894 |
01/22/2019 |
HM70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Scully Kim |
| K182632 |
01/08/2019 |
HS30 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Jee Young Ju |
| K173743 |
01/28/2019 |
Greenmedi Safety Filter Syringe |
Sang-A Frontec Co., Ltd |
Park Sung-soon |
| K181953 |
11/20/2019 |
SDS1.2 dental implant |
SDS Swiss Dental Solutions AG |
Martin Chares |
| K193040 |
11/30/2019 |
Resorbable Mesh Device |
SeaSpine Orthopedics Corporation |
Caryn Sailor |
| K192095 |
11/01/2019 |
CAPI 3 Immunotyping, Capillarys 3 Tera |
Sebia |
Karen Anderson |
| K192936 |
11/15/2019 |
Soltus 500 |
Sedecal., SA. |
Ma Luisa Gomez de Aguero |
| K192118 |
11/08/2019 |
CRP Vario |
Sentinel CH, Spa |
Patricia Dupe |
| K190225 |
11/05/2019 |
TAP Blood Collection Device |
Seventh Sense Biosystems, Inc. |
Tim Richards |
| K183143 |
01/03/2019 |
uCT 520, uCT 528 |
Shangai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K192672 |
11/20/2019 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd |
Xin Gao |
| K183137 |
01/11/2019 |
uMR 580, uMR 588 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin GAO |
| K182111 |
01/17/2019 |
DL Self-adhesive Electrode |
Shaoxing DL Healthcare Co., Ltd. |
Zhao Qingya |
| K192432 |
11/08/2019 |
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 |
Shenzhen Bosidin Technology Co., Ltd. |
Wang Jiaoyan |
| K191428 |
11/27/2019 |
ECG Cable |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K181215 |
01/02/2019 |
Infrared Thermometer |
Shenzhen Finicare Co., Ltd. |
Chao Li |
| K182636 |
01/10/2019 |
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Jiang Haosen |
| K181637 |
01/09/2019 |
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
Zhang Wei |
| K192087 |
11/01/2019 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
Kevin Zhang |
| K182869 |
01/09/2019 |
Fit SA |
Shofu Dental Corporation |
Mauro Malzyner |
| K192365 |
11/29/2019 |
Shoulder Innovations Total Shoulder System |
Shoulder Innovations Inc |
Don Running |
| K192777 |
11/22/2019 |
ADVIA Centaur CA 15-3 assay |
Siemens Healthcare Diagnostics, Inc. |
Anoop Joy |
| K192788 |
11/25/2019 |
ADVIA Centaur Cortisol (COR) |
Siemens Healthcare Diagnostics, Inc. |
Ian Thompson |
| K183244 |
01/24/2019 |
MAGNETOM Lumina |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K192061 |
11/21/2019 |
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 |
| K191891 |
11/06/2019 |
SOMATOM X.cite |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K182517 |
01/11/2019 |
MULTIX Impact |
Siemens Medical Solutions, Inc. |
Denise Adams |
| K183254 |
01/18/2019 |
Magnetom Vida |
Siemens Medical Solutions, USA, Inc. |
Cordell L. Fields |
| K190898 |
11/01/2019 |
Sight OLO |
Sight Diagnostics Ltd. |
Sarah Levy |
| K183542 |
01/02/2019 |
Signature Orthodontic System |
Signature Orthodontics |
Alfred Charles Griffin |
| K181338 |
01/17/2019 |
Imboki Knee Instrument System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K181190 |
01/17/2019 |
Pinehurst Anterior Cervical Plate System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K190577 |
11/27/2019 |
World Knee Total Knee Systems |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K181047 |
01/09/2019 |
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs |
Smart Glove Corporation Sdn.Bhd. |
Khon Pu Foo |
| K182323 |
01/18/2019 |
PICO 7Y Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Shruthi Bhat |
| K181204 |
01/10/2019 |
RENASYS Y-Connector; RENASYS TOUCH |
Smith & Nephew Medical Limited |
Sam Greenhalgh |
| K182489 |
01/16/2019 |
4CIS« Pinehurst Anterior Cervical Plate system |
Solco Biomedical Co., Ltd. |
Il Kim |
| K182648 |
01/29/2019 |
X5 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K183643 |
01/03/2019 |
Clear Image Aligners |
Specialty Appliance Works, Inc. |
Carolyn Thomas |
| K192603 |
11/22/2019 |
Spes Medica Subdermal Needle Electrodes |
Spes Medica S.r.l. |
Giorgio Facco |
| K183538 |
01/17/2019 |
VIVA combo RF System |
STARmed Co., Ltd. |
Jun-Young Jung |
| K190478 |
11/14/2019 |
Reprocessed ViewFlexÖ Xtra ICE Catheter |
Sterilmed, Inc. |
Jan Flegeau |
| K183294 |
01/03/2019 |
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack |
STERIS Corporation |
Anthony Piotrkowski |
| K183301 |
01/03/2019 |
PRO-LITE Sterilization Tray |
STERIS Corporation |
Jennifer Nalepka |
| K182827 |
01/31/2019 |
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 |
STERIS Corporation |
Marcia L. Benedict |
| K182568 |
01/03/2019 |
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
STERIS Corporation |
Bill Brodbeck |
| K183293 |
01/04/2019 |
VERIFY VH202 Indicator Tape |
STERIS Corporation |
Anthony Piotrkowski |
| K183297 |
01/03/2019 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
STERIS Corporation |
Jennifer Nalepka |
| K183295 |
01/04/2019 |
Celerity HP Chemical Indicator (CI) |
Steris Corporations |
Gregory Land |
| K183300 |
01/03/2019 |
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack |
STERIS Corporations |
Gregory Land |
| K191466 |
11/07/2019 |
SandShark Injectable Anchor (SIA) System |
Stimwave Technologies Inc. |
Elizabeth Greene |
| K192292 |
11/19/2019 |
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable |
Stryker |
April Malmborg |
| K183470 |
01/07/2019 |
Precision Ideal Eyes Arthroscopes |
Stryker |
Jessie Duong |
| K182305 |
01/07/2019 |
Stryker Facial iD Plating System |
Stryker |
Zainab Amini |
| K192207 |
11/22/2019 |
Trevo NXT ProVue Retriever |
Stryker |
Rhoda M Santos |
| K192122 |
11/22/2019 |
Trevo Trak 21 Microcatheter |
Stryker |
Rhoda Santos |
| K182968 |
01/25/2019 |
Hoffmann LRF System |
Stryker GmbH |
Jackie Perri |
| K192675 |
11/22/2019 |
VariAx Foot |
Stryker GmbH |
Jemin Dedania |
| K193034 |
11/29/2019 |
AXS Infinity LS Plus Long Sheath |
Stryker Neurovascular |
Shivani H Patel |
| K183071 |
01/10/2019 |
VLIFT-s Vertebral Body Replacement System |
Stryker Spine |
Renee Norby |
| K181056 |
01/24/2019 |
Reprocessed CS Diagnostic Electrophysiology Catheter |
Stryker Sustainability Solutions |
Mia McCorkel |
| K181993 |
11/01/2019 |
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) |
Sturdy Industrial Co., Ltd |
Wolfgang Huang |
| K190144 |
11/05/2019 |
MucoPEG |
SunBio, Inc. |
Sun S. Kim |
| K191784 |
11/15/2019 |
Gabriel Feeding Tube with Balloon, and EnFit Connector |
Syncro Medical Innovations, Inc. |
Sabry Gabriel |
| K192327 |
11/07/2019 |
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile |
Synthes (USA) Products LLC |
Thomas Shea |
| K192745 |
11/26/2019 |
DePuy Synthes Trauma Screws |
Synthes (USA) Products LLC / DePuy Orthopaedics Inc |
Keith Knapp |
| K182389 |
01/25/2019 |
Sysmex XN-L Automated Hematology Analyzer |
Sysmex America, Inc. |
Sharita Brooks |
| K190391 |
11/15/2019 |
TDM Plate and Screw Systems |
TDM Co. Ltd. |
Yougdae Kim |
| K191247 |
11/15/2019 |
SmartSPACE Shoulder System |
TechMah Medical LLC |
Mohamed R. Mahfouz |
| K191312 |
11/01/2019 |
Perfect PFE |
TensCare Ltd. |
Andrew Brown |
| K191986 |
11/10/2019 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| K183151 |
01/23/2019 |
Optilite IgA CSF Kit |
The Binding Site Group Ltd. |
Natasha Verhaak |
| K182198 |
01/31/2019 |
Panoura X-ERA PF/NF/MF |
The Yoshida Dental Mfg. Co., Ltd. |
Hidenori Watanabe |
| K192729 |
11/06/2019 |
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K183033 |
01/04/2019 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K191914 |
11/06/2019 |
Thermo Scientific Sensititre ARIS HiQ System |
Thermo Fisher Scientific |
Cynthia Knapp |
| K191918 |
11/06/2019 |
Thermo Scientific Sensititre ARIS HiQ System |
Thermo Fisher Scientific |
Cynthia Knapp |
| K182548 |
01/25/2019 |
Accucuff Cuff Pressure Indicator |
Tianjin Medis Medical Device Co., Ltd. |
Yongzhi Wu |
| K182507 |
01/21/2019 |
Tigon Medical Tissue Anchors |
Tigon Medical |
Jeremy Clark |
| K191075 |
11/22/2019 |
Healy |
TimeWaver Production GmbH |
Martin Wittmann |
| K191961 |
11/26/2019 |
OrthoGold |
Tissue Regeneration Technologies |
John Warlick |
| K182025 |
01/02/2019 |
ClearUP Sinus Pain Relief |
Tivic Health Systems Inc. |
Nina Peled |
| K183696 |
01/30/2019 |
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid |
Tornier, Inc. |
Moyees Kamara |
| K192792 |
11/20/2019 |
TranS1 AxiaLIF Plus System |
TranS1 |
Kristen Allen |
| K192877 |
11/22/2019 |
Senhance Surgical System |
TransEnterix, Inc. |
Kaitlyn Alexander |
| K182421 |
01/11/2019 |
Senhance Ultrasonic System |
TransEnterix, Inc. |
Stephanie M. Fitts |
| K183321 |
01/25/2019 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K181649 |
01/11/2019 |
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) |
Trudell Medical International |
Marianne Tanton |
| K182284 |
01/18/2019 |
Tyber Medical PT Interbody Spacer |
Tyber Medical LLC |
Mark F. Schenk |
| K192117 |
11/01/2019 |
Small VBRÖ |
ulrich GmbH & Co. KG |
Christoph Ulrich |
| K191171 |
11/13/2019 |
EchoGo Core |
Ultromics Ltd |
Melissa Clark |
| K182642 |
01/25/2019 |
GenesisZrÖ 4Y Zirconia |
United Dental Resources Corporation |
John Von Thaden |
| K192124 |
11/21/2019 |
Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories |
US Medical Innovations, LLC |
David Hinds |
| K192278 |
11/01/2019 |
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) |
UVision360 Inc. |
Allison London Brown |
| K192204 |
11/19/2019 |
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 |
| K192968 |
11/12/2019 |
IDENTIFY |
Varian Medical Systems, Inc. |
Peter J Coronado |
| K192935 |
11/15/2019 |
CAPERE Thrombectomy System |
Vascular Medcure, Inc. |
Jeffrey P DuMontelle |
| K183256 |
01/04/2019 |
GlideScope BFlex Single-Use Bronchoscope System |
Verathon Medical (Canada) ULC |
Teresa Davidson |
| K182456 |
01/17/2019 |
Study Watch |
Verily Life Sciences LLC |
Shilpa Mydur |
| K191497 |
11/01/2019 |
NextDent Denture 3D+ |
Vertex-Dental BV |
Loes Vloet-Emonts |
| K181461 |
01/04/2019 |
Rapid-iÖ Kit |
Vitrolife Sweden AB |
Nina Arvidsson |
| K180236 |
01/18/2019 |
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) |
VR MEDICAL TECHNOLOGY CO., LTD |
Lee Pan |
| K183097 |
01/10/2019 |
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream |
Weihai Kangzhou Biotechnology Engineering Co., Ltd |
Yong Qi |
| K190013 |
11/04/2019 |
WellDoc BlueStar |
WellDoc, Inc. |
Caroline York |
| K180822 |
01/28/2019 |
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System |
Wenzel Spine, Inc. |
Beckinam Nowatzke |
| K192908 |
11/14/2019 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K182895 |
01/25/2019 |
Wilson-Cook Achalasia Balloon |
Wilson-Cook Medical, Inc |
Theresa de Prat |
| K181893 |
01/29/2019 |
T-PLUS |
Wintecare SA |
Claudio Freti |
| K192202 |
11/12/2019 |
Clear21 |
World Class Technology Corporation |
Alan Kozlowski |
| K181377 |
01/11/2019 |
PROSTEP MICA Screw System |
Wright Medical Technology, Inc. |
Val Myles |
| K183357 |
01/21/2019 |
XableCath Crossing Catheter |
XableCath, Inc. |
Rick Gaykowski |
| K173847 |
01/16/2019 |
Disposable Ultra Reinforced Surgical Gown |
Xiantao Rayxin Medical Products Co., ltd. |
Liang Zhang |
| K182514 |
01/24/2019 |
Surgical Face Mask |
Xiantao Zhibo Non-woven Products Co., Ltd |
Yao Sanyu |
| K181805 |
01/11/2019 |
UV Phototherapy |
Xuzhou Kernel Medical Equipment Co., LTD. |
Jing Wang |
| K192320 |
11/26/2019 |
HealthCXR |
Zebra Medical Vision, Ltd. |
Flair Bar |
| K183514 |
01/14/2019 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Katherine Prendergast |
| K190497 |
11/20/2019 |
Ziehm 8000 |
Ziehm Imaging GmbH |
Steve Seeman |
| K181096 |
01/15/2019 |
Avenue P Cage System |
Zimmer Biomet Spine, Inc. |
Alex Pawlowski |
| K192236 |
11/05/2019 |
Fitmore Hip Stem |
Zimmer GmbH |
Roberto Tommasini |
| K181307 |
01/28/2019 |
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow |
Zimmer Inc |
Patricia Sandborn Beres |
| K192940 |
11/15/2019 |
CoolTone |
Zimmer MedizinSysteme GmbH |
Ute Hauss |
| K183457 |
11/05/2019 |
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head |
Zimmer, Inc. |
Rebecca Nofiz |
| K183136 |
01/30/2019 |
Zimmer Segmental System Proximal Femoral Component |
Zimmer, Inc. |
Jason Heckaman |
| K190518 |
11/22/2019 |
Color Liquid, Vita Liquid |
Zirkonzahn srl |
Julian Steger |
| K191631 |
11/01/2019 |
ZMAXX Dental Zirconia Blanks |
ZMAXX Bioceramics LLC |
Josef Wu |
| K182093 |
01/28/2019 |
ZOLL ECG Analysis Software |
ZOLL Manufacturing Corporation |
Zachary Nelson |
