| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K183159 |
11/15/2018 |
3M Clarity Aligners |
3M Company |
Yanine Garcia-Quezada |
| K183211 |
11/19/2018 |
3M Comply Hydrogen Peroxide Chemical Indicator |
3M Company |
Nadia Battah |
| K183209 |
11/19/2018 |
3M Comply Hydrogen Peroxide Indicator Tape |
3M Company |
Nadia Battah |
| K183276 |
11/23/2018 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K180087 |
01/12/2018 |
A.M. Surgical Intramedullary Fixation Device |
A.M. Surgical, Inc |
Gavriel Feuer |
| K183128 |
11/13/2018 |
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 |
Abbott |
Cody Johnson |
| K180040 |
01/05/2018 |
NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI |
Abbott Vascular |
Emily Zhao |
| K183066 |
11/05/2018 |
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C« with BioGUARDÖ Technology-3 Fr, 4 Fr, and 5 Fr Model |
Access Scientific, LLC |
Martina Nguyen |
| K183090 |
11/06/2018 |
Relieva Tract Balloon Dilation System |
Acclarent, Inc. |
Leena Sorathia |
| K180196 |
01/24/2018 |
On Call Express Mobile Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K180096 |
01/16/2018 |
GDT-1000 System |
AcuVu Inc. |
Sam Mostafavi |
| K180239 |
01/29/2018 |
Additive Orthopaedics Patient Specific 3D Printed Bone Segments |
Additive Orthopaedics, LLC |
Gregory Kowalczyk |
| K180244 |
01/29/2018 |
EnsoETM |
Advanced Cooling Therapy, Inc. d/b/a Attune Medical |
Erik Kulstad |
| K183180 |
11/19/2018 |
Caiman 5 Maryland |
Aesculap, Inc. |
Jessica Stigliano |
| K183203 |
11/19/2018 |
ELAN 4 Tools |
Aesculap, Inc. |
Kathy A. Racosky |
| K183275 |
11/23/2018 |
DR 800 with Tomosynthesis |
Agfa N.V. |
Wim Govaerts |
| K183121 |
11/09/2018 |
Qraypen |
AIOBIO Co., Ltd. |
Jongcheol Yoon |
| K180207 |
01/24/2018 |
Non-contact Infrared Thermometer |
Alicn Medical (Shenzhen), Inc |
Meisong Fang |
| K183319 |
11/30/2018 |
Triangle System |
AliveCor, Inc. |
Prabhu Raghavan |
| K183084 |
11/06/2018 |
Fuji Cervical Plate System |
Altus Partners, LLC |
Mark Melton |
| K180006 |
01/02/2018 |
AmCAD-UT Detection 2.2 |
AmCad BioMed Corporation |
Jack Yang |
| K180185 |
01/23/2018 |
BIO-C REPAIR |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto de Oliveria |
| K180199 |
01/24/2018 |
BIO-C TEMP |
Angelus Industria de Produtos Odontologicos S/A |
Paulo Sergio Calixto de Oliveira |
| DEN180004 |
01/22/2018 |
picoAMH ELISA |
Ansh Labs LLC |
Ajay Kumar |
| K180041 |
01/05/2018 |
BioCode Gastrointestinal Pathogen Panel (GPP) |
Applied Biocode, Inc. |
Robert Di Tullio |
| K180026 |
01/03/2018 |
Bowel Management Device, Bowel Management Irrigation Set |
Applied Medical Technology, Inc. |
Michelle Scott |
| K180191 |
01/23/2018 |
SuperBall Meniscal Repair System |
Arcuro Medical Ltd. |
Lee Ranon |
| K183229 |
11/20/2018 |
Argen Clear Aligner |
Argen Corporation |
Paul Cascone |
| K183306 |
11/28/2018 |
GLUCOCARD« W onyx Blood Glucose Monitoring System |
ARKRAY Factory, Inc. |
Yoshiharu Uehata |
| K183194 |
11/19/2018 |
Arthrex Eclipse Shoulder Prosthesis System |
Arthrex Inc. |
David L Rogers |
| K180118 |
01/16/2018 |
Arthrex NanoSuture Anchor |
Arthrex Inc. |
Rebecca R. Homan |
| K183070 |
11/05/2018 |
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K183062 |
11/05/2018 |
ASAHI Silverway |
Asahi Intecc Co., LTD. |
Yasuyuki Kawahara |
| K183074 |
11/05/2018 |
TENS and EMS Stimulator, TENS Stimulator |
Astek Technology Ltd. |
You-Jhe Lin |
| K180010 |
01/02/2018 |
AtriClip FLEX-V |
AtriCure, Inc. |
Brittany Lowe |
| K180138 |
01/17/2018 |
AtriCure cryoICE cryo-ablation probe (CRYO2) |
AtriCure, Inc. |
Melissa Smallwood |
| K180137 |
01/17/2018 |
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) |
AtriCure, Inc. |
Melissa Smallwood |
| K183065 |
11/05/2018 |
Coolrail Linear Pen |
AtriCure, Inc. |
Caitlin Wunderlin |
| K183148 |
11/13/2018 |
OKLand Patient Return Electrode Pad |
Auckland Medical Polymer(Tianjin) Co., Ltd. |
Bei Lei Gao |
| K180155 |
01/19/2018 |
Arm Type Blood Pressure Monitor |
Avita Corporation |
Steven Jhou |
| K183088 |
11/06/2018 |
ADVIA Centaur Erythropoietin (EPO) assay |
Axis-Shield Diagnostics Limited |
Claire Dora |
| K183025 |
11/01/2018 |
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component |
b-One Ortho Corp. |
Allison Gecik |
| K183045 |
11/02/2018 |
Eclipse 2L |
Balt USA, LLC |
Nancy Xu |
| K180061 |
01/08/2018 |
UltraCor Twirl Breast Tissue Marker |
Bard Peripheral Vascular, Inc. |
Meghan McKelvey |
| K183167 |
11/15/2018 |
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens |
Bausch & Lomb, Incorporated |
Glenn A. Davies |
| K183127 |
11/13/2018 |
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) |
Beckman Coulter, Inc. |
Elaine Marie Duncan |
| K183190 |
11/19/2018 |
NuStat |
Beeken Biomedical, LLC |
Richard A. Kendall |
| K180174 |
01/22/2018 |
Belun Ring |
Belun Technology Company Limited |
Leung Lap Wai Lydia |
| K180248 |
01/29/2018 |
VascuEase IC-1200-WH |
Bio Compression Systems, Inc. |
Barbara Whitman |
| K183282 |
11/26/2018 |
Biovitals Analytics Engine |
Biofourmis Singapore Pte. Ltd |
Kuldeep Singh Rajput |
| K183031 |
11/01/2018 |
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 ╡g/mL) |
bioMerieux SA |
Marine Taravant |
| K183166 |
11/15/2018 |
BacT/ALERT FA Plus; BacT/ALERT PF Plus |
bioMerieux, Inc. |
Mary Beth Anheuser |
| K183138 |
11/13/2018 |
Certain BellaTek Express and BellaTek Flex Abutments |
Biomet 3i |
Krupal Patel |
| K183162 |
11/15/2018 |
Affixus Hip Fracture Nail |
Biomet Inc. |
Dhaval Saraiya |
| K180238 |
01/29/2018 |
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT |
Biosense Webster, Inc. |
Phuong Chau |
| K183120 |
11/09/2018 |
EmboCube Embolization Gelatin |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K183265 |
11/23/2018 |
Selectra Catheters, Selectra Accessory Kit |
Biotronik, Inc. |
Jon Brumbaugh |
| K183080 |
11/05/2018 |
Mega Plus Spine System |
BK Meditech Co., Ltd |
Meredith Lee May |
| K180271 |
01/31/2018 |
NAVIOÖ Surgical System (NAVIO system) |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K180107 |
01/16/2018 |
Blue Sky Bio Aligner |
Blue Sky Bio LLC |
Albert Zickmann |
| K180102 |
01/16/2018 |
Embozene Color-Advanced Microspheres |
Boston Scientific |
Heidi Shearer |
| K180068 |
01/09/2018 |
ORISE Gel |
Boston Scientific |
Thomas Hirte |
| K180144 |
01/18/2018 |
Agile Esophageal Stent System |
Boston Scientific Corporation |
Kayla Mackey |
| K183085 |
11/06/2018 |
CoreDxÖ Pulmonary Mini-Forceps |
Boston Scientific Corporation |
Elena Nieves |
| K183177 |
11/16/2018 |
Nitinol Thermocouple (TCN) Electrode |
Boston Scientific Corporation |
Adele Shoustal |
| K183175 |
11/16/2018 |
BostonSight Scleral |
BostonSight |
Gene Guselli |
| K180211 |
01/25/2018 |
Freezpoint |
Bovie Medical Corp. |
Sam Niedbala |
| K183241 |
11/21/2018 |
BrainScope TBI (Model: Ahead 400) |
BrainScope Company Inc. |
Michael E Singer |
| K183303 |
11/27/2018 |
Brainsway Deep TMS System |
Brainsway Ltd. |
Moria Ankri |
| K183240 |
11/20/2018 |
Empower RF Catheter |
Broncus Medical, Inc |
Aradhana Dhanabalan |
| K183200 |
11/19/2018 |
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses |
C&E GP Specialist, Inc. |
Steve Wagner |
| K180069 |
01/09/2018 |
HDR MRI Lumen Marker |
C4 Imaging LLC |
Andrew Bright |
| K180269 |
01/31/2018 |
Cadwell Apollo System |
Cadwell Industries, Inc. |
Alison Hull |
| K180162 |
01/19/2018 |
VivaScope System |
Caliber Imaging & Diagnostics, Inc. |
Joel Radford |
| K183046 |
11/02/2018 |
Aquilion ONE (TSX-305A/6) V8.9 with AiCE |
Canon Medical Systems Corporation |
Paul Biggins |
| K183192 |
11/19/2018 |
CapsoCam Plus (SV-3) |
CapsoVision, Inc. |
Azimun Jamal |
| K183245 |
11/21/2018 |
Carestream DRX-1 System with DRX Plus 2530 Detectors |
Carestream Health, Inc. |
Gina L Maiolo |
| K180229 |
01/26/2018 |
RESCAN 700, CALLISTO eye |
Carl Zeiss Meditec AG |
Christian Muenster |
| K180003 |
01/02/2018 |
FORE-SIGHT ELITE Module Tissue Oximeter |
CAS Medical Systems, Inc. |
Ron Jeffrey |
| K183195 |
11/19/2018 |
VIVO |
Catheter Precision, Inc. |
Steve Adler |
| K180274 |
01/31/2018 |
Ventix Link Knotless Anchor with Inserter |
Cayenne Medical, Inc |
Shima Hashemian |
| K180121 |
01/16/2018 |
Rafugen DBM |
Cellumed Co., Ltd. |
JooWoong (Albert) Jang |
| K183149 |
11/13/2018 |
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim |
Central Medicare Sdn. Bhd. |
Muhammad Abdul Rahman |
| K180218 |
01/25/2018 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
Yi-Ping Lin |
| K180014 |
01/02/2018 |
Creme de La Femme Feminine Lubricant |
Cewal, Inc. dba Premiere Enterprises |
Jerome Vozoff |
| K183214 |
11/19/2018 |
Raven Lumbar Plate System |
Choice Spine, LP |
Kim Finch |
| K180104 |
01/16/2018 |
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant |
Church & Dwight Co., Inc |
Joelle Reinson |
| K180150 |
01/19/2018 |
PL8 Wrist Reconstruction Plate |
CITIEFFE S.r.l. |
Stefano Pullega |
| K183259 |
11/21/2018 |
IdysÖ TLIF TiVac |
Clariance SAS |
Clement Chaumont |
| K183255 |
11/21/2018 |
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device |
CoaguSense, Inc. |
Robin Bush |
| K183057 |
11/02/2018 |
PUMA-G System |
CoapTech LLC |
Jack Kent |
| K180070 |
01/09/2018 |
SpeediCath Flex Coude Pro |
Coloplast |
Troy Thome |
| K180258 |
01/30/2018 |
SpeediCath Standard |
Coloplast |
Ngoc Linh Pham Latchman |
| K180057 |
01/08/2018 |
VORTEK URETERAL DOUBLE LOOP STENT |
Coloplast Corp |
Cori Ragan |
| K183109 |
11/08/2018 |
ControlRad Trace Model 8 |
ControlRad, Inc. |
Guillaume Bailliard |
| K180205 |
01/24/2018 |
AVELLE Negative Pressure Wound Therapy System |
ConvaTec Limited |
Justin Lovelace |
| K180028 |
01/03/2018 |
Cook 810 Set, Desilets-Hoffman Introducer Set |
Cook Incorporated |
Carly Powell |
| K183036 |
11/01/2018 |
Dilator Sets |
Cook Incorporated |
David Lehr |
| K180182 |
01/23/2018 |
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter |
Cook Incorporated |
Samuel Engelman |
| K183051 |
11/02/2018 |
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set |
Cook Incorporated |
Yan Li |
| K180029 |
01/03/2018 |
Malecot Nephrostomy Catheter/Stent Set |
Cook Incorporated |
Minjin Choi |
| K183035 |
11/01/2018 |
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle |
Cook Incorporated |
Yan Li |
| K180054 |
01/08/2018 |
Royal Flush Plus High-Flow Catheter |
Cook Incorporated |
Jessica Swafford |
| K180216 |
01/25/2018 |
Seidmon Antegrade AQ Stent Set |
Cook Incorporated |
Rebecca Odulio (Li-Chun-Liu) |
| K180053 |
01/08/2018 |
Sof-Flex Ureteral Stent Set |
Cook Incorporated |
Minjin Choi |
| K183323 |
11/30/2018 |
UPJ Occlusion Balloon Catheter |
COOK Incorporated |
Johnathan Liu |
| K180034 |
01/04/2018 |
Weinmann Tracheostomy Exchange Set |
Cook Incorporated |
Paul Meyer |
| DEN180062 |
11/19/2018 |
EchoTip Insight Portosystemic Pressure Gradient Measuring System |
Cook Ireland Ltd. |
Jane Kennedy |
| K183020 |
11/01/2018 |
Endosee System |
CooperSurgical, Inc. |
Roaida Johnson |
| K180052 |
01/08/2018 |
UriSwab-Urine Collection, Transport and Preservation System |
Copan Italia S.p.A. |
Elisabetta Zanella |
| K180081 |
01/11/2018 |
RAILWAY Sheathless Access System |
Cordis Corporation |
Michelle Ragozzino Rodgers |
| K183239 |
11/20/2018 |
CoreLink F3DÖ Lateral System |
Corelink, LLC |
Steven Mounts |
| K183038 |
11/01/2018 |
Corin Optimized Positioning System (OPS) Plan |
Corin USA |
Lucinda Gerber |
| K183114 |
11/09/2018 |
Corin BiPolar-i |
Corin USA Limited |
Homer Trieu |
| K180037 |
01/05/2018 |
Beacon EUS Access System |
Covidien llc |
Rachel Silva |
| K180192 |
01/24/2018 |
Emprint Ablation Visualization Application |
Covidien, LLC |
Patti L. Arndt |
| K180149 |
01/19/2018 |
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide |
Covidien, llc |
Nancy Sauer |
| K180007 |
01/02/2018 |
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter |
Creagh Medical, Ltd. |
Shane Costello |
| K183072 |
11/05/2018 |
EndoFLIP System |
Crospon Ltd |
John O'Dea |
| K180252 |
01/30/2018 |
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank |
Crown Porcelain Dental Technology Co., Ltd. |
Chu Lien Fan |
| K183285 |
11/26/2018 |
cmTriage |
CureMetrix, Inc |
Kevin Harris |
| K180050 |
01/08/2018 |
CurvaFix Intramedullary Rodscrew System |
CurvaFix, Inc. |
Steve Dimmer |
| K183094 |
11/07/2018 |
CyclaPlex Correction System |
Cycla Orthopedics Ltd |
Rafi Herzog |
| K180247 |
01/29/2018 |
DAEHAN Adhesive Surface Electrodes |
Daehan Medical Systems Co., Ltd. |
Da Pin Jeong |
| K180232 |
01/29/2018 |
DAEHAN Disposable CUP Electrodes |
Daehan Medical Systems Co., Ltd. |
Da Roo Ha |
| K183201 |
11/19/2018 |
Hearing Healthcare Pro |
dB Diagnostic Systems, Inc. |
Steven Levine |
| K183315 |
11/30/2018 |
CustMBite Dental Guard |
Dental Choice Holdings, LLC |
Ron Story |
| K180184 |
01/23/2018 |
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System |
Dentalpoint AG |
Anja Lieberherr |
| K180065 |
01/09/2018 |
FUSION Plus Curing Light |
DentLight Inc. |
Richard Liu |
| K180044 |
01/08/2018 |
SIROLaser Blue |
Dentsply Sirona |
Karl J Nittinger |
| K183079 |
11/05/2018 |
Conometric Abutments |
Dentsply Sirona Inc. |
Karl Nittinger |
| K183077 |
11/05/2018 |
Delta Xtend Reverse Shoulder System |
DePuy (Ireland) |
Yayoi Fujimaki |
| K183054 |
11/02/2018 |
SYNMESH System |
DePuy Synthes Spine |
Michelle Hughes |
| K183206 |
11/19/2018 |
Dexcom G6 Continuous Glucose Monitoring System |
Dexcom, Inc. |
Bryan Osborne |
| K183223 |
11/20/2018 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K180209 |
01/24/2018 |
Diazyme 1,5-AG Assay |
Diazyme Laboratories Inc. |
Abhijit Datta |
| K180074 |
01/10/2018 |
Diazyme Lipoprotein (a) Assay |
Diazyme Laboratories, Inc. |
Abhijit Datta |
| K183103 |
11/07/2018 |
EMS Belt (Model MC0485) |
Dongguan Yingfeng Metal & Plastic Products Co., Ltd |
Zesheng Chen |
| K180106 |
01/16/2018 |
ThinkQA |
DOSIsoft |
Marc Uszynski |
| K183316 |
11/30/2018 |
Dr J Spinal and Epidural Needles |
Dr. Japan Co., Ltd. |
Mitsuko Uchida |
| K183230 |
11/20/2018 |
OneDraw A1C Test System |
Drawbridge Health, Inc. |
Annie Wright |
| K183292 |
11/26/2018 |
Topaz Mobile DR System |
DRGEM Corporation |
Ki-Nam Yang |
| K180275 |
01/31/2018 |
VAMP Optima closed blood sampling system |
Edwards Lifesciences LLC |
Jennifer Wilbur |
| K183260 |
11/23/2018 |
Sensilight Pro / Pistol IPL |
EL Global Trade Ltd. |
Shachar Raz |
| K180193 |
01/24/2018 |
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) |
El.En Electronic Engineering S.p.A. |
Paolo Peruzzi |
| K183037 |
11/01/2018 |
Monaco RTP System |
Elekta, Inc |
Kathryn Stinson |
| K183034 |
11/01/2018 |
MOSAIQ Oncology Information System |
Elekta, Inc |
Faiza Ahmed |
| K180224 |
01/26/2018 |
ELEMENT-TL |
Elemenic Co., Ltd. |
Jo Won Ju |
| K180001 |
01/02/2018 |
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant |
Embla Systems |
Sanjay Mehta |
| K180165 |
01/22/2018 |
Habib EndoHPB |
EMcision Ltd. |
Francois Poulin |
| K183205 |
11/19/2018 |
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System |
EmCyte Corporation |
Patrick Pennie |
| K180197 |
01/24/2018 |
Erchonia FX-635 |
Erchonia Corporation |
Steven Shanks |
| K183191 |
11/19/2018 |
6420 Ultrasound System |
Esaote, S.p.A. |
Massimo Polignano |
| K183052 |
11/02/2018 |
ID-Cap System |
etectRx, Inc. |
Susan Baumgartner |
| K180031 |
01/04/2018 |
Endopath Electrosurgery Probe Plus II |
Ethicon Endo-Surgery, LLC |
Carmen Ortiz |
| K183183 |
11/19/2018 |
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture |
Ethicon, Inc. |
Stephanie Saati |
| K183313 |
11/29/2018 |
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) |
Euroimmun US, Inc. |
Daniel Castellanos |
| K183142 |
11/13/2018 |
PathVisionXL |
Faxitron Bioptics LLC |
Ciaran Purdy |
| K180208 |
01/24/2018 |
Disposable Endoscopic Trocar |
Fengh Medical Co., Ltd. |
Jun Zhou |
| K183123 |
11/13/2018 |
microTargeting Guideline 4000 5.0 System |
FHC, Inc. |
Kelly Moeykens |
| K180047 |
01/08/2018 |
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System |
Fiab SpA |
Alberto Calabro |
| K183021 |
11/01/2018 |
ClearEndoclip |
Finemedix Co., Ltd. |
Heon-sik Lee |
| K183289 |
11/26/2018 |
ClearGrasp Snare |
Finemedix Co., Ltd. |
Hee Kyung Kwon |
| K180082 |
01/11/2018 |
geko T-2 and geko Plus R-2 |
Firstkind Ltd |
Neil Buckley |
| K183307 |
11/28/2018 |
Magma Spark Pro (Magma Spark Plus, Alpha) |
Formatk Systems Ltd. |
Amit Goren |
| K183059 |
11/02/2018 |
3nethra neo |
Forus Health Pvt. Ltd. |
Shruti Kashinath |
| K183032 |
11/01/2018 |
FUJIFILM Double Balloon Endoscope EI580BT |
FUJIFILM Corporation |
Randy Vader Vader |
| K183248 |
11/21/2018 |
Synapse Enterprise Viewer Version 1.0 |
FUJIFILM Corporation |
Randy Vader |
| K183235 |
11/20/2018 |
SonoSite SII Ultrasound System |
FUJIFILM SonoSite, Inc. |
Aditi Chaubal |
| K180023 |
01/03/2018 |
WIRION |
Gardia Medical Ltd. |
Vardit Segal |
| K180092 |
01/12/2018 |
Intellitorq |
Gauthier Biomedical, Inc. |
Austin Braganza |
| K183116 |
11/09/2018 |
Unity Network ID |
GE Healthcare |
Brandon O'Shea |
| K183204 |
11/19/2018 |
Bone VCAR (BVCAR) |
GE Medical Systems SCS |
Elizabeth Matthew |
| K180225 |
01/26/2018 |
GSI Viewer with GSI Fat Option |
GE Medical Systems SCS |
Peter Uhlir |
| K183210 |
11/19/2018 |
Thoracic VCAR with GSI Pulmonary Perfusion |
GE Medical Systems SCS |
Peter Uhlir |
| K183231 |
11/20/2018 |
SIGNA Premier |
GE Medical Systems, LLC |
Brian R. Zielski |
| K183182 |
11/19/2018 |
Critical Care Suite |
GE Medical Systems, LLC. |
Camille Vidal |
| K183202 |
11/19/2018 |
Deep Learning Image Reconstruction |
GE Medical Systems, LLC. |
Lee Bush |
| K183161 |
11/15/2018 |
SnapShot Freeze 2 |
GE Medical Systems, LLC. |
Laura Turner |
| K180152 |
01/19/2018 |
gel-e Flex |
gel-e, Inc. |
Elsa Abruzzo |
| DEN180060 |
11/15/2018 |
Plenity |
Gelesis, Inc. |
Eyal Ron |
| K180188 |
01/23/2018 |
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K180056 |
01/08/2018 |
Genesys Spine AIS-C Cervical Anchored Interbody System |
Genesys Spine |
Benjamin V. Keller |
| K183171 |
11/16/2018 |
ScopeSeal Duodenoscope Protective Device |
GI Scientific LLC |
Scott Miller |
| K180171 |
01/22/2018 |
PillCam Patency System |
Given Imaging Ltd. |
Hilla Debby |
| K180210 |
01/24/2018 |
CREO« Stabilization System |
Globus Medical Inc. |
Kelly J. Baker |
| K183119 |
11/09/2018 |
SI-LOK« Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS« Instruments |
Globus Medical Inc. |
Lori Burns |
| K180156 |
01/19/2018 |
SP-Fix« Spinous Process Fixation Plate, RELIEVE« Laminoplasty Fixation System |
Globus Medical Inc. |
Lori Burns |
| K183056 |
11/02/2018 |
ASSURE« Anterior Cervical Plate System |
Globus Medical, Inc. |
Kelly J. Baker |
| K180264 |
01/30/2018 |
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K180136 |
01/17/2018 |
BioNude Lubricant |
Good Clean Love, Inc. |
Wendy Strgar |
| K180086 |
01/12/2018 |
Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter |
Gyrus ACMI, Inc. |
Mary Anne Patella |
| K183160 |
11/15/2018 |
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge |
Haemonetics Corporation |
Nancy Bengtson |
| K183068 |
11/05/2018 |
Nitrile Glove Powder Free White |
Haining Medical Products Co., Ltd. |
Zhiming Yao |
| K180255 |
01/30/2018 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
Zheng Shujian |
| K183298 |
11/27/2018 |
HardyDisk AST Omadacycline 30╡g (OMC30) |
Hardy Diagnostics |
Anna Klavins |
| K180240 |
01/29/2018 |
Full Automatic(NIBP) Blood Pressure Monitor |
Health & Life Co. Ltd. |
J. S. Hsu |
| K183274 |
11/23/2018 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
James J. Rogers |
| K180079 |
01/10/2018 |
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation |
Hill-Rom Inc. |
Sarah Marie Fitzgerald |
| K183242 |
11/21/2018 |
ET IV SA Dental Implants |
Hiossen, Inc. |
Peter Lee |
| K183291 |
11/26/2018 |
Supria True64 Whole-Body X-Ray CT System |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K183253 |
11/21/2018 |
ValPro 2 Plus, VaPro 2 Plus Pocket |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K180233 |
01/29/2018 |
Eviva Stereotactic Guided Breast Biopsy System |
Hologic, Inc |
Brenda M Geary |
| K180279 |
01/31/2018 |
Silk'n MODEL H5003 device |
Home Skinovations Ltd. |
Amit Goren |
| K183154 |
11/14/2018 |
SM Electrodes |
Hong Qiangxing (Shen Zhen) Electronics Limited |
Xu Jianhua |
| K180125 |
01/16/2018 |
PowerLook Density Assessment Software |
iCAD, Inc |
John DeLucia |
| K183213 |
11/19/2018 |
IceSense 3, ProSense, MultiSense |
IceCure Medical LTD. |
Elisabeth Sadka |
| K180036 |
01/05/2018 |
SMAXEL CO2 Surgical Laser System |
IDS, LTD. |
Kwang Yeong Ahn |
| DEN180001 |
01/12/2018 |
IDx-DR |
IDx, LLC |
Michael D. Abramoff |
| K183145 |
11/13/2018 |
IlluminOss Photodynamic Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K180129 |
01/17/2018 |
Imbio Segmentation Editing Tool software |
Imbio, LLC |
Vipul Goel |
| K183048 |
11/02/2018 |
Quantisal II Oral Fluid Collection Device |
Immunalysis Corporation |
Wenying (Jessica) Zhu |
| K180202 |
01/24/2018 |
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts |
Immuno Concepts, NA, Ltd. |
Eric S Hoy |
| K180126 |
01/16/2018 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K183043 |
11/02/2018 |
0.071ö ID MantaRay Reperfusion Catheter, 0.055ö ID MantaRay Reperfusion Catheter, 0.045ö ID MantaRay Reperfusion Catheter, 0.035ö ID MantaRay Reperfusion Catheter |
Imperative Care Inc. |
Jake Wolenberg |
| K180169 |
01/22/2018 |
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, |
Imperative Care Inc. |
Jake Wolenberg |
| K183024 |
11/01/2018 |
Implacil Implant System |
Implacil de Bortoli Material Odontologico Ltda |
Thiago Toni |
| K180263 |
01/30/2018 |
EcoFit Vit E Acetabular System |
implantcast Gmbh |
Juliane Hoeppner |
| K183198 |
11/19/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordan |
| K180189 |
01/23/2018 |
InMode System with Fractora3D/3D-90 Applicators |
Inmode MD Ltd. |
Amit Goren |
| K180140 |
01/18/2018 |
ProFlex Laser Fibers |
InnovaQuartz LLC |
Stephen E Griffin |
| K180078 |
01/10/2018 |
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System |
Innovasis, Inc. |
Marshall McCarty |
| K183064 |
11/05/2018 |
TxTi IBF System |
Innovasis, Inc. |
Marshall McCarty |
| K180045 |
01/08/2018 |
Omnipod DASH Insulin Management System |
Insulet Corporation |
Matthew King |
| K183184 |
11/19/2018 |
FlareHawk Interbody Fusion System |
Integrity Implants Inc |
Lauren Kamer |
| K183224 |
11/20/2018 |
SureForm 45, SureForm 45 Reloads |
Intuitive Surgical |
Nadine Nasr |
| K180033 |
01/04/2018 |
8mm Monopolar Curved Scissors |
Intuitive Surgical, Inc |
Gayle Perry |
| K183086 |
11/06/2018 |
da Vinci X and Xi Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K183139 |
11/13/2018 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K183107 |
11/08/2018 |
Intuitive Surgical Vessel Sealer Extend |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K183311 |
11/29/2018 |
Ivenix Infusion System (IIS) |
Ivenix, Inc. |
John J. Sokolowski |
| K183284 |
11/26/2018 |
INTRAcel RF Microneedle System |
Jeisys Medical Inc. |
Sugun Lee |
| K180259 |
01/30/2018 |
Sterile Hypodermic Needle for Single Use |
Jiangsu Shenli Medical Production Co., Ltd |
Tina Cai |
| K183044 |
11/02/2018 |
JTK Dental Implant System |
Jiangyin Jintech Biotech Co., Ltd. |
Jie Zhang |
| K180146 |
01/18/2018 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
| K183264 |
11/23/2018 |
Flex-THOR scope |
KARL STORZ Endoscopy-America, Inc. |
Nozomi Yagi |
| K180131 |
01/17/2018 |
Vicks RapidRead Digital Thermometer |
Kaz USA, Inc., A Helen of Troy Company |
Matt J. Baun |
| K180084 |
01/11/2018 |
Ultrasound System SONIMAGE MX1 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K183287 |
11/26/2018 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fe |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K183092 |
11/07/2018 |
Kuros TLIF Cage |
Kuros Biosciences BV |
Yvonne P. Bovell |
| K183168 |
11/16/2018 |
OpenLoc-L Spinal Fixation System |
L&K Biomed Co., Ltd. |
Jihyeon Seo |
| K183117 |
11/09/2018 |
PathLoc-L MIS Spinal System |
L&K Biomed Co., Ltd. |
Jihyeon Seo |
| K183247 |
11/21/2018 |
dpl Faceware |
LED Technologies, Inc. |
Lloyd Nelson |
| K183118 |
11/09/2018 |
dpl SpotLite |
LED Technologies, Inc. |
Lloyd Nelson |
| K180071 |
01/09/2018 |
STYLO Interbody Fusion Device |
Legend Spine Technologies |
Gwendolyn DeBoer |
| K183102 |
11/07/2018 |
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody |
Leica Biosystems Newcastle Limited |
Jeremy Allen |
| K183100 |
11/07/2018 |
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra |
Leica Biosystems Newcastle Limited |
Jeremy Allen |
| K180114 |
01/16/2018 |
AEON Retrieval Bag |
Lexington Medical Inc. |
Donna Gasper |
| K183286 |
11/26/2018 |
17HK701G-W |
LG Electronics Inc. |
Jinhwan Jun |
| K180215 |
01/25/2018 |
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System |
Life Spine Inc. |
Randy Lewis |
| K180166 |
01/22/2018 |
Life Spine Lumbar Fixation System (SENTRY) |
Life Spine, Inc. |
Randy Lewis |
| K183110 |
11/08/2018 |
LIVIA |
LifeCare Ltd. |
Amnon Nahum Sharon |
| K183173 |
11/16/2018 |
LIGHTMED Ultrasound System |
Lightmed USA, Inc |
Hedy Chiang |
| K183042 |
11/02/2018 |
SMR Lateralized Connectors with screws |
Limacorporate S.p.A. |
Roberto Gabetta |
| K183115 |
11/09/2018 |
MTS Levofloxacin 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K183140 |
11/13/2018 |
MTS Tetracycline 0.016 - 256 ug/mL |
Liofilchem s.r.l. |
Fabio Brocco |
| K183262 |
11/23/2018 |
EsoCheck CCD Cell Collection Device |
Lucid Diagnostics, Inc. |
Lishan Aklog |
| K183112 |
11/08/2018 |
DiLumen Endolumenal Interventional Knife (ôDiLumen IKÖö) |
Lumendi, LLC |
Dennis Daniels |
| K183023 |
11/01/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K183030 |
11/01/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K180180 |
01/23/2018 |
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
Inae Kim |
| K180098 |
01/16/2018 |
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 |
Maquet Critical Care AB |
Jerker Aberg |
| K180046 |
01/08/2018 |
Masimo Rad-97 and Accessories |
Masimo Corporation |
Sindura Penubarthi |
| K183105 |
11/08/2018 |
Mimics Medical |
Materialise NV |
Carina Martins |
| K180249 |
01/29/2018 |
OmniPore DUROMAX Surgical Implants |
Matrix Surgical Holdings, LLC/Matrix Surgical USA |
John O'Shaughnessy |
| K180270 |
01/31/2018 |
Cellvizio 100 Series Systems with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K180151 |
01/19/2018 |
MC3 Jugular Dual Lumen Catheter |
MC3 Incorporated |
Adam Viitala |
| K180089 |
01/12/2018 |
Medacta Shoulder System Short Humeral Diaphysis |
Medacta International SA |
Stefano Baj |
| K183029 |
11/01/2018 |
MOTO Partial Knee System |
Medacta International SA |
Stefano Baj |
| K183219 |
11/20/2018 |
Trio-CT Triple Lumen Catheter |
Medical Components Inc. (dba MedComp) |
Courtney Nix |
| K180242 |
01/29/2018 |
HeRO Symphony, HeRO ES, HeRO solo/duet |
Medical Predictive Science Corporation |
Will King |
| K180091 |
01/12/2018 |
UNiD Spine Analyzer |
Medicrea International |
David Ryan |
| K180090 |
01/12/2018 |
CureÖ Lumbar Plate System |
Meditech Spine, LLC |
Bruce Dunaway |
| K180101 |
01/16/2018 |
HEALIX ADVANCE KNOTLESS BR Anchor |
Medos International SARL |
Ashley Goncalo |
| K183279 |
11/23/2018 |
HEALIX Ti ANCHOR with DYNACORD |
Medos International SARL |
N/A N/A |
| K180222 |
01/25/2018 |
Reaxon Plus |
Medovent GmbH |
Peter Meier |
| K180021 |
01/03/2018 |
Proton Positioing and Immobilization Devices |
MEDTEC Inc dba CIVCO Medical Solutions and CIVCO Radiotherap |
Alena Newgren |
| K183129 |
11/13/2018 |
Medtronic Total Hip Arthroplasty System |
Medtronic Advanced Energy |
Gina Cunsolo |
| K183174 |
11/16/2018 |
FlexCath Advance Steerable Sheath and Dilator |
Medtronic CryoCath LP |
Natalie Sadeghi |
| K183197 |
11/19/2018 |
PYRAMESHÖ Implant System |
Medtronic Sofamor Danek USA, INC. |
ANkit K. Shah |
| K180030 |
01/03/2018 |
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) |
Medtronic, Inc. |
Nancy Cameron |
| K180122 |
01/16/2018 |
TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) |
Medtronic, Inc. |
Nancy Cameron |
| K180022 |
01/03/2018 |
Athena Cervical Plate System |
Medyssey USA, Inc. |
Shawn Kim |
| K180004 |
01/02/2018 |
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens |
Menicon Co., Ltd. |
Kenichi Tanaka |
| K183189 |
11/19/2018 |
Ultra OTC Facial Toning System |
Micro Current Technology, Inc. |
David Suzuki |
| K183185 |
11/19/2018 |
Riptide Aspiration System (Riptide Large Bore Aspiration System) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Nancy Drew |
| K183022 |
11/01/2018 |
Solitaire 4 Revascularization Device |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Helen Chow |
| K180018 |
01/02/2018 |
Disposable Hot Biopsy Forceps |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K180282 |
01/31/2018 |
MIS Internal Hex Dental Implant System |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K183163 |
11/15/2018 |
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix |
Motiva USA, LLC |
ALberto Quesada Rivera |
| K180100 |
01/16/2018 |
MRIaudio PREM System |
MRIaudio |
Joe Caruso |
| K183047 |
11/02/2018 |
Nalu Neurostimulation System |
Nalu Medical, Inc |
Michele Chin-Purcell |
| K183236 |
11/20/2018 |
Rotium Bioresorbable Wick |
Nanofiber Solutions, LLC |
Ronald L. Bracken |
| K180181 |
01/23/2018 |
Natus Quantum |
Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) |
Sanjay Mehta |
| K183126 |
11/13/2018 |
Electrosurgical accessory |
New Deantronics Taiwan Ltd |
Jane Liu |
| K180257 |
01/30/2018 |
InCore« Lapidus System |
Nextremity Solutions, Inc. |
Greg Denham |
| K183069 |
11/05/2018 |
NobelZygoma 0░ |
Nobel Biocare AB |
Charlemagne Chua |
| K180123 |
01/16/2018 |
Breast BI 7 MR Coil 1.5T Mammavention |
Noras MRI products GmbH |
Jens Heidenmann |
| K183169 |
11/16/2018 |
Pulse 2.0, Pulse Pro 2.0 |
NormaTec Industries, LP |
Albert G. Sanford |
| K183328 |
11/30/2018 |
Pulse Rx 2.0, Pulse Pro Rx 2.0 |
NormaTec Industries, LP |
Albert G. Sanford |
| K180186 |
01/23/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K180038 |
01/05/2018 |
NuVasive Pulse System |
NuVasive, Incorporated |
Olga Lewis |
| K180198 |
01/24/2018 |
NuVasive« VuePoint« II OCT System |
NuVasive, Incorporated |
Michelle Cheung |
| K183089 |
11/06/2018 |
Air Next |
NuvoAir AB |
Max Ladow |
| K183055 |
11/02/2018 |
Vector Hammertoe Correction System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K183158 |
11/15/2018 |
NxStage Cartridge Express with Speedswap |
NxStage Medical, Inc. |
Christina Marabella |
| K180237 |
01/29/2018 |
Rezum System |
NxThera, Inc. |
Kathy Simpson |
| K183132 |
11/13/2018 |
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
O & M Halyard, Inc. |
Angela L. Bunn |
| K183053 |
11/02/2018 |
Olympus Small Intestinal Capsule Endoscope System |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K180200 |
01/24/2018 |
ESG-300, APU-300, Pressure Reducer, MAPC Probes |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K183329 |
11/30/2018 |
Laser Hair Therapy |
OMM Imports, Inc. D/B/A Zero Gravity |
Moti Shenfarber |
| K183199 |
11/19/2018 |
TRIO Handpiece |
OmniGuide, Inc. |
Samuel Wade |
| K183215 |
11/19/2018 |
Focus TENS Therapy, Model PM710-M/-L |
Omron Healthcare, Inc. |
Renee Thornborough |
| K180130 |
01/17/2018 |
ELEOSÖ Bipolar Acetabular System |
Onkos Surgical, Inc. |
Jan Triani |
| K180241 |
01/29/2018 |
Orthocaps Twinaligner |
Ortho Caps GmbH |
Wajeeh Khan |
| K180025 |
01/03/2018 |
Centurion POCT System |
Orthofix Inc. |
Jacki Koch |
| K180179 |
01/23/2018 |
Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw |
Orthofix Inc. |
Jacki Koch |
| K180109 |
01/16/2018 |
STARband, STARlight, St. Louis Band |
Orthomerica Products, Inc |
David C. Kerr |
| K183220 |
11/20/2018 |
OrthoScan TAU Mini C-Arm |
Orthoscan, Inc. |
Richard Westrich |
| K183267 |
11/23/2018 |
DyeVertÖ NG Contrast Reduction System, DyeVertÖ PLUS EZ Contrast Reduction System, DyeTectÖ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVertÖ PLUS EZ Contrast Reduction System |
Osprey Medical, Inc. |
Melanie Hess |
| K183309 |
11/29/2018 |
stentfix OTSC System Set |
Ovesco Endoscopy AG |
Marc O. Schurr |
| K180064 |
01/09/2018 |
OsteoFab Patient Specific Cranial Device |
Oxford Performance Materials, Inc. |
M. Beth Pashko |
| K180173 |
01/22/2018 |
Freespira |
Palo Alto Health Sciences, Inc. |
Simon Thomas |
| K180228 |
01/26/2018 |
II-Type Intervertebral Spacer |
Paonan Biotech Co., Ltd. |
Vivi Tsai |
| K180230 |
01/26/2018 |
NEST Interbody System |
Paonan Biotech Co., Ltd. |
Tony Lin |
| K180226 |
01/26/2018 |
TREND II Spinal Fixation System- STEP Series |
Paonan Biotech Co., Ltd. |
Vivi Tsai |
| K183228 |
11/20/2018 |
HammerToe Compression System |
Paragon 28, Inc. |
Eric Lintula |
| K180172 |
01/22/2018 |
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroP |
Paragon Vision Sciences |
Rich Jefferies |
| K180194 |
01/24/2018 |
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System |
Paragonix Technologies, Inc. |
Leo Basta |
| K180105 |
01/16/2018 |
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister |
Penumbra, Inc. |
Richard Kimura |
| K180008 |
01/02/2018 |
Penumbra System |
Penumbra, Inc. |
Richard Kimura |
| K183296 |
11/27/2018 |
REAL Immersive System |
Penumbra, Inc. |
Mary Rose |
| K183133 |
11/13/2018 |
MRCP+ v1.0 |
Perspectum Diagnostics Ltd |
Jaco Jacobs |
| K180195 |
01/24/2018 |
Frigitronics adapter |
Phakos |
Olivier Aumaitre |
| K180015 |
01/02/2018 |
Philips Incisive CT |
Philips Healthcare (Suzhou) Co., Ltd. |
Gordon Shu |
| K180017 |
01/02/2018 |
MX40 Release C.01 |
Philips Medical Systems |
Theresa Poole |
| K183063 |
11/05/2018 |
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K183101 |
11/07/2018 |
Zenition 50 |
Philips Medical Systems Nederland BV |
Sumit Kumar |
| K183040 |
11/01/2018 |
Zenition 70 |
Philips Medical Systems Nederland BV |
Sumit Kumar |
| K180234 |
01/29/2018 |
physiQ Heart Rhythm Module |
physiQ Inc. |
George Allen Hides |
| K183322 |
11/30/2018 |
physIQ Heart Rhythm and Respiratory Module |
physIQ, Inc |
George Allen Hides |
| K180019 |
01/02/2018 |
CAAS Workstation |
Pie Medical Imaging BV |
Annemiek Bouts |
| K183060 |
11/02/2018 |
CervAlignÖ Anterior Cervical Plate System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Jaclyn Holli |
| K180020 |
01/02/2018 |
HemoScreen Hematology Analyzer |
PixCell Medical Technologies, Ltd. |
Yaaya Ben-Yosef |
| K180167 |
01/22/2018 |
Playtex Stella Tampons |
Playtex Manufacturing, Inc. |
Ludjane Fiorillo |
| K183270 |
11/23/2018 |
Silent Nite sl |
Prismatik Dentalcraft, Inc. |
Mythili Reguraman |
| K183165 |
11/15/2018 |
Pristine Scope |
Pristine Surgical |
Stewart B. Davis |
| K180080 |
01/10/2018 |
FIBERGRAFT BG Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S Bagga |
| K180011 |
01/02/2018 |
Pulmonx Chartis Tablet Console |
Pulmonx Corporation |
Sherry Kim |
| K180111 |
01/16/2018 |
ClearGuard HD Antimicrobial Barrier Cap |
Pursuit Vascular, Inc. |
Douglas Killion |
| K180157 |
01/19/2018 |
QT ECG |
QT Medical, Inc. |
Ruey-Kang Chang |
| K183111 |
11/08/2018 |
Contour 24 |
Quality Electrodynamics, LLC |
Eric Yeh |
| K180154 |
01/19/2018 |
QiF Blood and Fluid Warmer |
Quality In Flow Ltd. |
Neta Sherman |
| K180158 |
01/19/2018 |
Surgical Laser fibers |
Quanta System SPA |
Francesco Dell'Antonio |
| K180265 |
01/31/2018 |
COMPACT TOUCH Ophthalmic Ultrasound System |
Quantel Medical |
Maureen O'Connell |
| K180027 |
01/03/2018 |
ACCUSYTE 3D Fiducial Marker |
Radiation Products LLC |
John D Corbitt |
| K183146 |
11/13/2018 |
Ranfac Cartilage Biopsy Needle |
Ranfac Corporation |
Eric Kreuz |
| K183302 |
11/27/2018 |
KY Banksy Aloe |
RB Health (US) LLC |
Elizabeth Viguerie |
| K183049 |
11/02/2018 |
Reliance Lumbar IBF System |
Reliance Medical Systems LLC |
Bret Berry |
| K180206 |
01/24/2018 |
neuromate Gen III |
Renishaw Mayfield Sarl |
Stephane Vinot |
| K183193 |
11/19/2018 |
MREplus+ Software |
Resoundant Inc |
Bernard Horwath |
| K183226 |
11/20/2018 |
Care Orchestrator Essence |
Respironics Inc. |
Michelle Brinker |
| K180051 |
01/08/2018 |
XSTAT 30, 1-Pack |
RevMedx, Inc. |
Amy K. Pointer |
| K180272 |
01/31/2018 |
Saniclave 250 |
REVOLUTIONARY SCIENCE |
Isaac Erickson |
| K183188 |
11/19/2018 |
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF |
Richard Wolf Medical Instruments Corporation |
Mike Loiterman |
| K180183 |
01/23/2018 |
Ritter Dental Implant System |
Ritter Implants GmbH & Co. KG |
Wemer Schmitz |
| K180201 |
01/24/2018 |
Route 92 Medical Access System |
Route 92 Medical, Inc. |
Kirsten Valley |
| K180139 |
01/18/2018 |
Safe Secure Sterilization Pouches and Rolls |
Safe Secure Packing Co., Ltd. |
Howard Jia |
| K183073 |
11/05/2018 |
SMG Anterior Cervical Plate System |
Sapphire Medical Group |
Anthony Ruggiero |
| K183266 |
11/23/2018 |
EP-TRACER System |
Schwarzer CardioTek GmbH |
Tatjana Nuber |
| K180176 |
01/22/2018 |
SeaSpine NewPort Spinal System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K183083 |
11/06/2018 |
Shoreline Cervical Interbody RT System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K180148 |
01/19/2018 |
ATS Thermal Imaging Probe, ATS Patient Interface Unit |
Securus Medical Group, Inc. |
William J. Gorman |
| K183187 |
11/19/2018 |
nextaro Transfer System, nextaro va |
SFM Medical Devices GmbH |
Olaf Br÷msen |
| K183143 |
11/13/2018 |
uCT 520, uCT 528 |
Shangai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K180177 |
01/22/2018 |
Guidewire |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K180178 |
01/22/2018 |
Introducer Set |
Shanghai Kindly Medical Instruments Co., Ltd. |
Xu Jianhai |
| K183186 |
11/19/2018 |
Head Coil û 12, Head Coil û 32, Carotid Coil û 8, Temporomandibular Joint Coil û 4, Infant Coil û 24, Cardiac Coil û 24, Foot & Ankle Coil - 24 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K183137 |
11/13/2018 |
uMR 580, uMR 588 |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin GAO |
| K183170 |
11/16/2018 |
uWS-CT |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K183164 |
11/15/2018 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd. |
Xin Gao |
| K183144 |
11/13/2018 |
uMC 560i |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K183122 |
11/09/2018 |
810nm Diode Laser System |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd |
Yvonne Xue |
| K180260 |
01/30/2018 |
Powder Free Vinyl Patient Examination Gloves (Yellow, White) |
Shanxi Hongjin Plastic Technology Co., Ltd |
Wu Zhigang |
| K183058 |
11/02/2018 |
Arm-type Electronic Blood Pressure Monitor |
Shenzhen BSX Technology Electronics Co., Ltd. |
Zhijian Zhao |
| K183288 |
11/26/2018 |
Transcutaneous Electrical Nerve Stimulator |
Shenzhen Kentro Medical Electronics Co., Ltd |
Zewu Zhang |
| K183238 |
11/20/2018 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K180016 |
01/02/2018 |
Home Use IPL Beauty Device |
Shenzhen Mismon Technology Co., Ltd |
Vicky Yang |
| K183277 |
11/23/2018 |
SpO2 Sensor |
Shenzhen Upnmed Equipment Co., Ltd. |
Fu Jian |
| K180073 |
01/09/2018 |
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set |
Shenzhen Vitavitro Bio-tech Co., Ltd |
Jenny Lin |
| K180262 |
01/30/2018 |
SICAT Endo |
SICAT GmbH & Co. KG |
Manfred Breuer |
| K183222 |
11/20/2018 |
MAGNETOM Terra |
Siemens Medical Solutions USA Inc. |
Milind Dhamankar |
| K180039 |
01/05/2018 |
ACUSON Juniper Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K180067 |
01/09/2018 |
ACUSON X800 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K183272 |
11/23/2018 |
AI Rad Companion (Engine) |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K183268 |
11/23/2018 |
AI-Rad Companion (Cardiovascular) |
Siemens Medical Solutions USA, Inc. |
Kimberly Rendon |
| K183271 |
11/23/2018 |
AI-Rad Companion (Pulmonary) |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K183221 |
11/20/2018 |
MAGNETOM Amira, MAGNETOM Sempra |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K183244 |
11/21/2018 |
MAGNETOM Lumina |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K183254 |
11/21/2018 |
Magnetom Vida |
Siemens Medical Solutions, USA, Inc. |
Cordell L. Fields |
| K183310 |
11/29/2018 |
Encore System |
Siesta Medical, Inc |
Michael Kolber |
| K183317 |
11/30/2018 |
AdvantageRib System |
SIG Medical Corporation |
Andrew Davison |
| K180134 |
01/17/2018 |
Ensizor Monopolar Endoscopic Scissors |
Slater Endoscopy, LLC |
John Starkey |
| K180124 |
01/16/2018 |
ZQuiet |
Sleeping Well,LLC |
Daniel Webster |
| K183280 |
11/23/2018 |
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs |
Smart Glove Corporation Sdn. Bhd. |
Khon Pu Foo |
| K180221 |
01/25/2018 |
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs |
Smart Glove Corporation Sdn.Bhd |
Foo Khon Pu |
| K180277 |
01/31/2018 |
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter |
Smith & Nephew, Inc. |
Allison Chan |
| K183232 |
11/20/2018 |
Double ENDOBUTTON Fixation Device |
Smith and Nephew, Inc. |
Dharaben Desai |
| K183208 |
11/19/2018 |
Suprasorb A + Ag ôRö |
Speciality Fibres and Materials Ltd. |
Lindie Turvey |
| K183176 |
11/16/2018 |
Endotoxin Activity Assay (EAA) |
Spectral Medical Inc. |
Danijela Domljanovic |
| K180220 |
01/25/2018 |
SAGICO OSI Spinal System by Osimplant |
Spinal Analytics & Geometrical Implant Co, LLC |
James J Gibson Jr. |
| K180002 |
01/02/2018 |
Rampart One Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K183091 |
11/06/2018 |
Elaris Pedicle Screw System |
SpineWelding AG |
Joerg Mayer |
| K180141 |
01/18/2018 |
SPIWay Endonasal Access Guide |
SPIWay, LLC |
Eugene Chen |
| K183320 |
11/30/2018 |
Ilumien Optis, Optis Integrated, Optis Mobile |
St. Jude Medical (now Abbott Medical) |
Steve Vitale |
| K183099 |
11/07/2018 |
QUANTIEN Measurement System |
St. Jude Medical (now Abbott Medical) |
Ka Zoua Xiong |
| K183225 |
11/20/2018 |
Stabil Orthopaedic Solutions Total Knee System |
Stabil Orthopaedic Solutions, LLC |
Jim Moore |
| K183027 |
11/01/2018 |
Steerable catheter control system |
Stereotaxis, Inc. |
Kenneth H. Lock |
| K183294 |
11/27/2018 |
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack |
STERIS Corporation |
Anthony Piotrkowski |
| K183301 |
11/27/2018 |
PRO-LITE Sterilization Tray |
STERIS Corporation |
Jennifer Nalepka |
| K183293 |
11/27/2018 |
VERIFY VH202 Indicator Tape |
STERIS Corporation |
Anthony Piotrkowski |
| K183297 |
11/27/2018 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
STERIS Corporation |
Jennifer Nalepka |
| K183295 |
11/27/2018 |
Celerity HP Chemical Indicator (CI) |
Steris Corporations |
Gregory Land |
| K183300 |
11/27/2018 |
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack |
STERIS Corporations |
Gregory Land |
| K183172 |
11/16/2018 |
Stryker SternalPlate System |
Stryker |
Hans Geiger |
| K183196 |
11/19/2018 |
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker |
Stryker Corporation |
Andrea Wallen-Gerding |
| K183104 |
11/08/2018 |
Mini Cannulated Headed and Headless Screw Set |
Stryker GmbH |
Sanja Jahr |
| K183039 |
11/01/2018 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
Tina Mornak |
| K183249 |
11/21/2018 |
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage |
STRYKER SPINE |
Deirdre Jayko |
| K183071 |
11/05/2018 |
VLIFT-s Vertebral Body Replacement System |
Stryker Spine |
Renee Norby |
| K183153 |
11/14/2018 |
Microwave Ablation System |
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
Guofang Ma |
| K183325 |
11/30/2018 |
Modus Nav |
Synaptive Medical Inc. |
Maham Ansari |
| K180077 |
01/10/2018 |
NeuroQ 3.8 |
Syntermed |
Kenneth Van Train |
| K183113 |
11/09/2018 |
DePuy Synthes Maxillofacial Portfolio - MR Conditional |
Synthes (USA) Products LLC |
Rebecca Reiter |
| K180213 |
01/25/2018 |
Titanium TomoFix Medial High Tibia Plate Anatomical |
Synthes (USA) Products, LLC |
Stephan Jepards |
| K183067 |
11/05/2018 |
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Paul Liu |
| K180115 |
01/16/2018 |
TWBM Pump |
Taiwan Biomaterial Co., Ltd. |
Monoj Mon Kalita |
| K180253 |
01/30/2018 |
Sheridan Endobronchial Tubes |
Teleflex Medical |
Lori Pfohl |
| K183081 |
11/06/2018 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
Nicholas Wong |
| K180135 |
01/17/2018 |
THD Anopress with THD SensyProbe |
THD SpA |
Maurizio Pantaleoni |
| K180063 |
01/09/2018 |
OCM-G1 Attachment |
The Anspach Effort, Inc. |
Tamara J West |
| K180099 |
01/16/2018 |
Optilite High Sensitivity C-Reactive Protein Kit |
The Binding Site Group Ltd |
Kirsty Samuels |
| K183151 |
11/14/2018 |
Optilite IgA CSF Kit |
The Binding Site Group Ltd. |
Natasha Verhaak |
| DEN180059 |
11/06/2018 |
Nerivio Migra |
Theranica Bioelectronics ltd |
Alon Ironi Ironi |
| K183033 |
11/01/2018 |
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 |
| K183324 |
11/30/2018 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K180127 |
01/17/2018 |
TCAT (R) THA Instrument Tray Set |
THINK Surgical Inc. |
John Hahn |
| K183290 |
11/26/2018 |
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 |
Thrombolex, Inc. |
Amy Katsikis |
| K180159 |
01/19/2018 |
Klassic« Knee System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K183217 |
11/19/2018 |
IPL Hair Removal Device |
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. |
Aaron Zhai |
| K183305 |
11/28/2018 |
Crossing Support Catheter |
Tractus Vascular LLC |
Janet Burpee |
| K183098 |
11/07/2018 |
Senhance Surgical System |
TransEnterix, Inc. |
Michele Jans |
| K180163 |
01/19/2018 |
TransEnterix Senhance Surgical System |
TransEnterix, Inc. |
Stephanie Fitts |
| K183321 |
11/30/2018 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K183106 |
11/08/2018 |
TruAbutment DS |
TruAbutment Inc. |
Kiyoon Nam |
| K183108 |
11/08/2018 |
Combined Aerobika OPEP and VersaPAP device |
Trudell Medical International |
Marianne Tanton |
| K183243 |
11/21/2018 |
Velofix TLIF Cage |
U&i Corporation |
Jee Ae Bang |
| K180075 |
01/10/2018 |
MINUET LCD, MINUET LCD eco |
Unimom Co. |
Hong Sang-Hyun |
| K183263 |
11/23/2018 |
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope |
UNiPACK Medical Corporation |
Joe Pomparelli |
| K180219 |
01/25/2018 |
JO H2O Flavored Personal Lubricants |
United Consortium |
Stephanie Morris |
| K180083 |
01/11/2018 |
Silicone Personal Lubricant, ALL-IN-ONE |
United Consortium |
Stephanie Morris |
| K183312 |
11/29/2018 |
Conformity Stem |
United Orthopedic Corporation |
Lois Ho |
| K180214 |
01/25/2018 |
Repris Bladder Injection System |
URO-1, Inc. |
Thomas Lawson |
| K183134 |
11/13/2018 |
ArcTV Transvaginal Sling System |
UroCure LLC |
John Nealon |
| K183152 |
11/14/2018 |
Phoenix |
US Bionics, Inc. (DBA suitX) |
Kelly Mettler |
| K183212 |
11/19/2018 |
Nexus DR Digital X-ray Imaging System with stitching |
Varex Imaging Corporation |
Michael Van Ryn |
| K183179 |
11/16/2018 |
CAPERE Thrombectomy System |
Vascular Medcure, Inc. |
Jeffrey P. DuMontelle |
| K180128 |
01/17/2018 |
Warrior 14 guidewire |
Vascular Solutions, Inc |
Becky Astrup |
| K180088 |
01/12/2018 |
TrapLiner catheter |
Vascular Solutions, Inc. |
Beka Vite |
| K183256 |
11/21/2018 |
GlideScope BFlex Single-Use Bronchoscope System |
Verathon Medical (Canada) ULC |
Teresa Davidson |
| K180217 |
01/25/2018 |
VESTEX Apparel |
Vestagen Protective Technologies, Inc. |
Scott Pease |
| K180175 |
01/22/2018 |
SignalMark Lung Biopsy Site Marker |
ViewPoint Medical, Inc. |
Thomas Kane |
| K180204 |
01/24/2018 |
CranioMaxillofacial Fixation (CMF) System - CMF Visionare |
Visionare LLC |
Mariane de Oliveira Quinzani |
| K183078 |
11/05/2018 |
VitalConnect Platform, VitalPatch Biosensor |
VitalConnect, Inc. |
Cynthia Merrell |
| K180161 |
01/19/2018 |
Viz CTP |
Viz.ai, Inc. |
Gregory Ramina |
| K183050 |
11/02/2018 |
GLISSANT Intimate Lubricant |
Vjuvenate, LLC |
Karyn Eilber |
| K183147 |
11/13/2018 |
BrackFix |
VOCO GmbH |
M. Th. Plaumann |
| K180236 |
01/29/2018 |
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) |
VR MEDICAL TECHNOLOGY CO., LTD |
Lee Pan |
| K183141 |
11/13/2018 |
LINK MP Monoblock Hip Prosthesis |
Waldemar Link GmbH & Co. KG |
Andre von Malotki |
| K183097 |
11/07/2018 |
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 |
| K183156 |
11/15/2018 |
V-Laser |
WONTECH Co., Ltd. |
Erin Park |
| K180024 |
01/03/2018 |
SALVATION Midfoot Nail |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K183026 |
11/01/2018 |
Wright Jones Fracture System |
Wright Medical Technology, Inc. |
Antonio Ayala |
| K183041 |
11/01/2018 |
Full Digital Colour Doppler Ultrasonic Diagnostic System |
Wuhan Zoncare Bio-medical Electronics Co., Ltd |
Chenglin Tian |
| K180153 |
01/19/2018 |
X-spine Cortical Bone Screw System |
X-spine Systems, Inc. |
Charlene Brumbaugh |
| K180243 |
01/29/2018 |
Infinity-Lock Button System |
Xiros Ltd |
Stephen Seed |
| K180076 |
01/10/2018 |
Ti 3Z Interbody System |
Zavation Medical Products, LLc |
Katie Motley |
| K180227 |
01/26/2018 |
Polaris Spinal Growth System |
Zimmer Biomet Spine, Inc. |
Anthony Michael Maahs |
| K183136 |
11/13/2018 |
Zimmer Segmental System Proximal Femoral Component |
Zimmer, Inc. |
Jason Heckaman |
| K183304 |
11/28/2018 |
Prettau, ICE, Z-White zirconia blanks |
Zirkonzahn srl |
Julian Steger |
