| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| 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 |
| 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 |
| K192266 |
11/21/2019 |
M. Blue Adjustable Shunt System |
Aesculap, Inc. |
Kathy A Racosky |
| K191650 |
11/01/2019 |
LEGION System |
Alcon Research, LLC |
Nickerson Hill |
| 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 |
| 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 |
| 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 |
| K192782 |
11/29/2019 |
ASAHI CROSSWALK Peripheral Support Catheter |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawuhara |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K192738 |
11/26/2019 |
ETEST Delafloxacin (DFX) (0.002-32 ╡g/mL) |
BioMerieux SA |
Sophie Quiblier |
| 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 |
| 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 |
| 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 |
| K190330 |
11/04/2019 |
DRX-Evolution/Plus with Dual Energy |
Carestream Health, Inc. |
Carolyn Wagner |
| 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 |
| K183666 |
11/14/2019 |
EBA One 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 |
| K192198 |
11/06/2019 |
Conformis Hip System |
Conformis, Inc. |
Paul Smolenski |
| DEN180062 |
11/20/2019 |
EchoTip Insight Portosystemic Pressure Gradient Measuring System |
Cook Ireland Ltd. |
Jane Kennedy |
| K190143 |
11/04/2019 |
LARS AC Band Device |
Corin USA |
Lucinda Gerber |
| 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 |
| 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 |
| 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 |
| K192157 |
11/22/2019 |
6450 Ultrasound system |
Esaote, S.p.A. |
Piet DeJong |
| K192842 |
11/15/2019 |
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High |
Eurotrol B.V. |
Elisanne Biemans |
| 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 |
| K191987 |
11/27/2019 |
Orapeutic |
Forward Science |
Brian Pikkula |
| K192150 |
11/13/2019 |
AMICUS Separator System |
Fresenius Kabi AG |
Aunica Jones |
| 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 |
| 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 |
| K192819 |
11/08/2019 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Kenny M Bello |
| 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 |
| 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 |
| 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 |
| K191201 |
11/15/2019 |
EM SA Implant System |
Hiossen, Inc. |
Peter Lee |
| K192264 |
11/08/2019 |
HIVOX Spopad EMS SP-911, SP-921 |
Hivox Biotek Inc. |
Marx Lee |
| 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 |
| K192109 |
11/05/2019 |
KOALA |
IB Lab GmbH |
Richard Ljuhar |
| K190397 |
11/15/2019 |
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA |
Immunalysis Corporation |
Yang Yang |
| K190529 |
11/25/2019 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| 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 |
| 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 |
| K190512 |
11/22/2019 |
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare |
Intelligent Endoscopy |
Melissa Clark |
| 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 |
| 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 |
| K190958 |
11/09/2019 |
Neodent Implant System |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| 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 |
| K182712 |
11/23/2019 |
DEXIS CariVu 3-in-1 by KaVo |
Kaltenbach & Voigt GmbH |
Stefan Trampler |
| 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 |
| 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 |
| K190721 |
11/14/2019 |
LongBow Ti |
Life Spine Inc. |
Angela Batker |
| 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 |
| K192299 |
11/21/2019 |
LZI Cotinine II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| 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 |
| K192126 |
11/22/2019 |
AMIStem-P Short Neck |
Medacta International SA |
Stefano Baj |
| K192297 |
11/08/2019 |
APTUS Wrist Arthrodesis Plates |
Medartis AG |
Andrea Kiefer-Schweizer |
| K192891 |
11/07/2019 |
Laparoscope Lens Shield Device (LENS) |
Medeon Biodesign, Inc |
Tsung-Yu Hsieh |
| K191026 |
11/07/2019 |
MEDIP PRO |
MEDICALIP Co., Ltd |
Yoon Bo Chung |
| 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 |
| K192336 |
11/22/2019 |
Navigated Anterolateral Disc Prep Instruments |
Medtronic Sofamor Danek USA, INC. |
Parwinder Singh |
| K192347 |
11/14/2019 |
ST Internal Implant System |
Megagen Implant Co. Ltd |
You Jung Kim |
| K192907 |
11/26/2019 |
Advocate PTA Catheter |
Merit Medical Systems Inc. |
Mark Mullaney |
| 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 |
| 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 |
| K190661 |
11/09/2019 |
Omics Core |
NantHealth, Inc. |
Aleece Nolasco |
| 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 |
| K192153 |
11/07/2019 |
Portux CAD/CAM Disc |
New Stetic S.A. |
Juan David Jaramillo G. |
| 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 |
| K191032 |
11/27/2019 |
fMRI Hardware System |
NordicNeurolab AS |
Chandana Gurung Bhandari |
| 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 |
| 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 |
| K181839 |
11/21/2019 |
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray |
OraLabs, Inc. |
Gary Schlatter |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K190710 |
11/29/2019 |
EliA SymphonyS Immunoassay |
Phadia AB |
Carina Magnusson |
| 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 |
| 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 |
| K191903 |
11/22/2019 |
BruxZir GT (Gum Tissue) Color |
Prismatik Dentalcraft, Inc. |
Mythili Reguraman |
| K192858 |
11/05/2019 |
A1AT Genotyping Test |
Progenika Biopharma S.A., A Grifols Company |
Diego Tejedor |
| K183018 |
11/01/2019 |
VPro5 |
Propel Orthodontics LLC |
Bryce Way |
| K191959 |
11/08/2019 |
QuantX Breast MRI Biopsy Guidance Plugin |
Qlarity Imaging |
Robert Tomek |
| K190797 |
11/18/2019 |
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) |
Reed Medical (Zhejiang) Co., Ltd. |
Lu Zhong Zhong |
| K192270 |
11/22/2019 |
LEva Pelvic Digital Health System |
Renovia Inc. |
Gina Prochilo-Cawston |
| K191693 |
11/01/2019 |
BC-5 |
Reveallux, Corp |
Justin D Linn |
| K181845 |
11/25/2019 |
Pivot System Sterilization case |
RP Medical, Inc. |
Jim Barley |
| K182892 |
11/26/2019 |
TRAUS Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Jong Woo |
| K191488 |
11/21/2019 |
SAM IO Intraosseous Access System |
SAM« Medical Products, Inc. |
Jeff Lipps |
| 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 |
| K192672 |
11/20/2019 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd |
Xin Gao |
| 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 |
| K192087 |
11/01/2019 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
Kevin Zhang |
| 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 |
| 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 |
| K190898 |
11/01/2019 |
Sight OLO |
Sight Diagnostics Ltd. |
Sarah Levy |
| K190577 |
11/27/2019 |
World Knee Total Knee Systems |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K192603 |
11/22/2019 |
Spes Medica Subdermal Needle Electrodes |
Spes Medica S.r.l. |
Giorgio Facco |
| K190478 |
11/14/2019 |
Reprocessed ViewFlexÖ Xtra ICE Catheter |
Sterilmed, Inc. |
Jan Flegeau |
| 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 |
| K192207 |
11/22/2019 |
Trevo NXT ProVue Retriever |
Stryker |
Rhoda M Santos |
| K192122 |
11/22/2019 |
Trevo Trak 21 Microcatheter |
Stryker |
Rhoda Santos |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K191075 |
11/22/2019 |
Healy |
TimeWaver Production GmbH |
Martin Wittmann |
| K191961 |
11/26/2019 |
OrthoGold |
Tissue Regeneration Technologies |
John Warlick |
| K192792 |
11/20/2019 |
TranS1 AxiaLIF Plus System |
TranS1 |
Kristen Allen |
| K192877 |
11/22/2019 |
Senhance Surgical System |
TransEnterix, Inc. |
Kaitlyn Alexander |
| K192117 |
11/01/2019 |
Small VBRÖ |
ulrich GmbH & Co. KG |
Christoph Ulrich |
| K191171 |
11/13/2019 |
EchoGo Core |
Ultromics Ltd |
Melissa Clark |
| 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 |
| K191497 |
11/01/2019 |
NextDent Denture 3D+ |
Vertex-Dental BV |
Loes Vloet-Emonts |
| K190013 |
11/04/2019 |
WellDoc BlueStar |
WellDoc, Inc. |
Caroline York |
| K192908 |
11/14/2019 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K192202 |
11/12/2019 |
Clear21 |
World Class Technology Corporation |
Alan Kozlowski |
| K192320 |
11/26/2019 |
HealthCXR |
Zebra Medical Vision, Ltd. |
Flair Bar |
| K190497 |
11/20/2019 |
Ziehm 8000 |
Ziehm Imaging GmbH |
Steve Seeman |
| K192236 |
11/05/2019 |
Fitmore Hip Stem |
Zimmer GmbH |
Roberto Tommasini |
| 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 |
| 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 |
