| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K173041 |
12/20/2018 |
3DIEMME RealGUIDE |
3DIEMME Ltd. |
Alessandro Montroni |
| K173435 |
02/09/2018 |
3M Attest Rapid Readout Biological Indicator |
3M Company |
Nadia Battah |
| K181838 |
12/20/2018 |
Sinusway Dilation System |
3NT Medical Ltd. |
Ehud Bendory |
| K172294 |
02/22/2018 |
Osteotomy Truss System (OTS) |
4Web, Inc. |
Jessee Hunt |
| K173579 |
02/12/2018 |
ThoreconÖ Fixation System |
A&E Medical Corporation |
Dana Rodriguez |
| K183128 |
12/12/2018 |
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 |
Abbott |
Cody Johnson |
| K172885 |
02/20/2018 |
HydroPICC |
Access Vascular, Inc |
Elizabeth Kinnal |
| K171646 |
02/16/2018 |
ACISTCVi« Contrast Delivery System |
ACIST Medical Systems, Inc. |
Melissa Sommerfeld |
| K171629 |
02/01/2018 |
ABCcolla Bone Graft |
ACRO Biomedical Co., Ltd. |
Dar-Jen Hsieh |
| K172512 |
02/02/2018 |
ACRO HCG Pregnancy Rapid Test |
ACRO Biotech, Inc. |
Joseph Fan |
| K181908 |
12/03/2018 |
Action Trackchair |
Action Manufacturing Inc. |
Alan Macht |
| K171557 |
02/06/2018 |
AcQRef Introducer Sheath |
Acutus Medical, Inc. |
Brenda Clay |
| K181405 |
12/10/2018 |
Hailie Sensor |
Adherium (NZ) Ltd |
Chris Mander |
| K172324 |
02/23/2018 |
Axiostat Chitosan Hemostatic Dressing |
Advamedica Inc. |
Leo Mavely |
| K180244 |
02/28/2018 |
EnsoETM |
Advanced Cooling Therapy, Inc. d/b/a Attune Medical |
Erik Kulstad |
| K182404 |
12/27/2018 |
STERRAD VELOCITY Biological Indicator |
Advanced Sterilization Products (ASP) |
Sun Choi |
| K170683 |
02/20/2018 |
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments |
Aesculap, Inc. |
Jessica Stigliano |
| K182032 |
12/21/2018 |
SterilContainer S System |
Aesculap, Inc. |
Paul Amudala |
| K172348 |
02/16/2018 |
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 |
Aesku Diagnostics GmbH & Co. KG |
Sandra Reuter |
| K182664 |
12/07/2018 |
FiXcision |
Agency for Medical Innovations GmbH |
Martin Hohlrieder |
| K182902 |
12/11/2018 |
Precision1 |
Alcon Laboratories, Inc. |
Alicia Plesnarski |
| K173303 |
02/23/2018 |
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) |
Alfa Scientific Designs, Inc |
Naishu Wang |
| K173212 |
02/15/2018 |
Instant-view-PLUS immunochemical Fecal Occult Blood Test |
Alfa Scientific Designs, Inc. |
Wen Hua Fan |
| K170623 |
02/27/2018 |
ACE Hemoglobin A1c (HbA1c) Reagent |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC |
Barbara Phillips |
| K180826 |
12/21/2018 |
Natrelle 133 Plus MICROCELL Tissue Expander |
Allergan |
Melissa Pathmajeyan |
| K172042 |
02/27/2018 |
NeuroNav System, NeuroSmart System |
Alpha Omega Engineering Ltd. |
Maysana Mousa |
| K182845 |
12/27/2018 |
minisono |
Alpinion Medical Systems Co., Ltd. |
Boyeon CHO |
| K180867 |
12/28/2018 |
AmCAD-UO |
AmCad BioMed Corporation |
Jack Yang |
| K172953 |
02/06/2018 |
Acid Etchant |
American Orthodontics |
Trang Adams |
| K173749 |
12/06/2018 |
AMRA Profiler |
AMRA Medical AB |
Janne West |
| K172058 |
02/13/2018 |
CT6485, CT12885 |
Analogic Corporation |
Karen Provencher |
| K171375 |
02/06/2018 |
Gammex PI Breach Detect Powder Free Surgical Glove |
Ansell Healthcare Products LLC |
Robert Mahler |
| K182593 |
12/18/2018 |
KET-1 Blood Ketone Monitoring System |
Apex Biotechnology Corp. |
Lisa Liu |
| K172624 |
02/13/2018 |
Voyant 5mm Fusion Device |
Applied Medical Resources Corporation |
Andrew Nguyen |
| K181756 |
12/18/2018 |
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle |
AprioMed AB |
Katrin Svensson |
| K182681 |
12/14/2018 |
AC5 Topical Gel |
Arch Therapeutics, Inc. |
Terrence W. Norchi |
| K182280 |
12/10/2018 |
ARK Tramadol Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K181935 |
12/04/2018 |
Endoform Reconstructive Template - Non Absorbable |
Aroa Biosurgery Ltd. |
Tina O'Brien |
| K182361 |
12/18/2018 |
Arthrex Compression FT Screws |
Arthrex Inc. |
Rebecca R. Homan |
| K181555 |
12/21/2018 |
Arthrex Fracture Adapter Hemi Shoulder Prosthesis |
Arthrex Inc. |
David L. Rogers |
| K180118 |
02/12/2018 |
Arthrex NanoSuture Anchor |
Arthrex Inc. |
Rebecca R. Homan |
| K180768 |
12/14/2018 |
Arthrex SwiveLock Anchors |
Arthrex Inc. |
Jessica L. Singelais |
| K182420 |
12/20/2018 |
ASAHI Corsair Pro XS |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K171933 |
02/12/2018 |
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K182878 |
12/18/2018 |
Integra Salto Total Ankle System |
Ascension Orthopedics |
Divya Savant |
| K173324 |
02/27/2018 |
ALTA Anterior Cervical Interbody Spacer |
Astura Medical |
Thomas Purcell |
| K180138 |
02/15/2018 |
AtriCure cryoICE cryo-ablation probe (CRYO2) |
AtriCure, Inc. |
Melissa Smallwood |
| K180137 |
02/15/2018 |
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) |
AtriCure, Inc. |
Melissa Smallwood |
| K183065 |
12/04/2018 |
Coolrail Linear Pen |
AtriCure, Inc. |
Caitlin Wunderlin |
| K171476 |
02/27/2018 |
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) |
Awareness Technology, Inc. |
Steve Andrus |
| K182012 |
12/21/2018 |
ADVIA Centaur Calcitonin (CALCT) assay |
Axis-Shield Diagnostics Limited |
Claire Dora |
| DEN170045 |
02/14/2018 |
Banyan BTI |
Banyan Biomarkers, Inc. |
Steven P. Richieri |
| K173381 |
02/22/2018 |
Nexxis OR |
Barco n.v. |
Eric Caus |
| K171671 |
02/23/2018 |
Prismaflex System 8.10 |
Baxter Healthcare Corporation |
Rick Lukacovic |
| K182320 |
12/20/2018 |
BD Contoured Base Pen Needle |
Becton, Dickinson and Company |
Meriam Youssef |
| K173523 |
02/09/2018 |
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) |
Becton, Dickinson and Company |
Monica E. Giguere |
| K172789 |
02/01/2018 |
Specimen Retrieval Bag |
Beijing HangTian KaDi Technology R&D Institute |
Liying Zhang |
| K171361 |
02/05/2018 |
BETTERCARE PLATFORM - ADVANCED WEB CLIENT |
Bettercare S.L. |
Bernat Sales |
| K173643 |
02/24/2018 |
Trilor Disks, Blocks and Arches |
Bioloren S.R.L. |
Ratti Umberto |
| K181766 |
12/10/2018 |
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance |
bioMerieux, Inc |
Cherece L. Jones |
| K181412 |
12/21/2018 |
VITEK MS |
bioMerieux, Inc. |
Jennifer Jines |
| K183162 |
12/14/2018 |
Affixus Hip Fracture Nail |
Biomet Inc. |
Dhaval Saraiya |
| K173411 |
02/08/2018 |
Comprehensive Segmental Revision System (SRS) |
Biomet Manufacturing Corp. |
Patricia Sandborn Beres |
| K173826 |
02/07/2018 |
THP Hip Fracture Plating System |
Biomet, Inc. |
Annette Minthorn |
| K171179 |
02/09/2018 |
BR Type Implant System |
Biotem Co.,Ltd. |
Hong Koo Yeo |
| K183265 |
12/13/2018 |
Selectra Catheters, Selectra Accessory Kit |
Biotronik, Inc. |
Jon Brumbaugh |
| K173569 |
02/23/2018 |
Ultrasound System 1300 |
BK Medical ApS |
Karen Provencher |
| K183080 |
12/10/2018 |
Mega Plus Spine System |
BK Meditech Co., Ltd |
Meredith Lee May |
| K172390 |
02/18/2018 |
Optima Coil System |
Blockade Medical, LLC (d.b.a. Balt USA) |
Rebecca K. Pine |
| K182065 |
12/13/2018 |
EVOLUX CAD/CAM PMMA BLOCKS |
Blue Dent Dental |
Adriana Paula T I Gomes |
| K180107 |
02/09/2018 |
Blue Sky Bio Aligner |
Blue Sky Bio LLC |
Albert Zickmann |
| K173400 |
02/09/2018 |
ORISE Tissue Retractor System |
Boston Scientific |
Thomas Hirte |
| K173877 |
02/15/2018 |
BOWA Neutral Electrodes |
BOWA-electronics GmbH & Co. KG |
Wolf-Ruediger Fritz |
| K181785 |
12/19/2018 |
Modified BrainScope One |
BrainScope Company Inc. |
Michael E Singer |
| DEN170021 |
12/20/2018 |
SEM Scanner (Model 200) |
Bruin Biometrics, LLC |
Ya-Chen Tonar |
| K180359 |
12/13/2018 |
BTL-FR2000 |
BTL Industries, Inc. |
David Chmel |
| K173800 |
02/02/2018 |
Camber Spine Technologies SPIRA - VÖ Open Matrix Corpectomy Cage |
Camber Spine Technologies |
Michael Black |
| K173689 |
02/23/2018 |
Ophthalmic Software Platform RX |
Canon Inc. -Medical Equipment Group |
Shinji Mori |
| K182601 |
12/14/2018 |
Vitrea Software Package, VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K181174 |
12/11/2018 |
Cardinal Health Sterilization Wrap |
Cardinal Health 200 LLC |
Jillian Connery |
| K182790 |
12/14/2018 |
Cardio-TriTest v6.5 |
Cardio-Phoenix Inc. |
Marc Bisnaire |
| K182397 |
12/13/2018 |
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
Cardiovascular Systems Inc. |
Kris Miller |
| K183000 |
12/29/2018 |
ViperCath XC Peripheral Exchange Catheter |
Cardiovascular Systems, Inc. |
Erika Huffman |
| K173924 |
02/05/2018 |
DRX-Revolution Nano Mobile X-ray System |
Carestream Health, Inc. |
Victoria A. Wheeler |
| K182424 |
12/18/2018 |
NuFACE FIX Skin Toning Device |
Carol Cole Company dba NuFACE |
Donald Ellis |
| K182149 |
12/19/2018 |
FFRangio System |
CathWorks Ltd |
Miriam Ivenshitz |
| K173145 |
02/28/2018 |
CereMetrix Silver |
CereMetrix Corp |
John A Kelley |
| K180014 |
12/21/2018 |
Creme de La Femme Feminine Lubricant |
Cewal, Inc. dba Premiere Enterprises |
Jerome Vozoff |
| K181344 |
12/14/2018 |
C.T.M Mobility Scooter |
CHIEN TI ENTERPRISE CO., LTD. |
Vivian Lo |
| K171637 |
02/26/2018 |
OpClear System |
Cipher Surgical Ltd |
Justin Buch |
| K182339 |
12/12/2018 |
LEUCADIA AUTOLOKÖ Pedicle Screw System |
ClearView Orthopedic Development, LLC |
Hartmut Loch |
| K172490 |
02/06/2018 |
eUnity |
Client Outlook Inc. |
Christie Eby |
| K182116 |
12/19/2018 |
BA310 Abutment, BIA310 Implant/Abutment |
Cochlear Americas |
Beth Murray |
| K173501 |
02/09/2018 |
Meridian Vaginal Positioning System (VPS) |
Coloplast |
Diane Brinza |
| K180070 |
02/02/2018 |
SpeediCath Flex Coude Pro |
Coloplast |
Troy Thome |
| K173527 |
02/12/2018 |
Digitex Delivery Device |
Coloplast A/S |
Nikita Basandra |
| K182831 |
12/10/2018 |
SabreLine and SabreGuard Laser Fibers |
Coloplast Corp |
Cori Ragan |
| K173352 |
02/15/2018 |
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) |
Concentric Medical, Inc. |
Rhoda M. Santos |
| K181120 |
12/21/2018 |
2.8 mm/3.3 mm PopLok Suture Anchors |
ConMed Corporation |
Diana L. Nader-Martone |
| K182446 |
12/19/2018 |
TruShot with Y-Knot All-Suture Anchor |
ConMed Corporation |
Diana L. Nader-Martone |
| K181529 |
12/06/2018 |
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection |
Contego Medical, LLC |
Elizabeth Saylors |
| K181463 |
12/13/2018 |
DuraSheath Introducer Sheath System |
Contract Medical International GmbH |
Jan Kloboucnik |
| K180846 |
12/19/2018 |
Arterial Pressure Monitoring Set/Tray |
Cook Incorporated |
Johnathan Liu |
| K183036 |
12/20/2018 |
Dilator Sets |
Cook Incorporated |
David Lehr |
| K182709 |
12/26/2018 |
One-Step Suprapubic Introducer |
Cook Incorporated |
Carly Powell |
| K171662 |
02/01/2018 |
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ure |
Cook Incorporated |
Carly Powell |
| K171604 |
02/15/2018 |
R÷sch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip |
Cook Incorporated |
Ian Herrman |
| K171600 |
02/16/2018 |
Renal Access Cobra Catheter, Kumpe Access Catheter |
Cook Incorporated |
Samuel Engelman |
| DEN170055 |
12/12/2018 |
Retrograde Intubation Set |
Cook Incorporated |
Hui Ouyang |
| K180830 |
12/20/2018 |
Reuter Tip Deflecting Wire Guide |
Cook Incorporated |
Jennifer L. Allman |
| K171994 |
02/22/2018 |
Silicone Peripherally Inserted Central Venous Catheter Set/Tray |
Cook Incorporated |
Johnathan Liu |
| K171601 |
02/23/2018 |
Ultraxx Nephrostomy Balloon Catheter |
Cook Incorporated |
Minjin Choi |
| K172044 |
02/27/2018 |
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action |
Cook Ireland Ltd |
Laura Graham |
| K181920 |
12/11/2018 |
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker |
CooperVision, Inc. |
Marie Dutton |
| K183239 |
12/19/2018 |
CoreLink F3DÖ Lateral System |
Corelink, LLC |
Steven Mounts |
| K173288 |
02/15/2018 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K183369 |
12/28/2018 |
COR12 ECG |
Corscience GmbH & Co. |
Karlheinz Trost |
| K173678 |
02/28/2018 |
Diode Laser Cap |
Cosmo Far East Technology Limited |
Bob An |
| K172361 |
02/16/2018 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Sarah Tang |
| K173270 |
02/20/2018 |
Tri-Staple 2.0 Reinforced Reload |
Covidien |
Rebecca Magnanimo |
| K173244 |
02/08/2018 |
superDimension Navigation System V7.2 |
Covidien LLC |
Kristi Fox |
| K182008 |
12/14/2018 |
Phasix ST Mesh with Echo 2 Positioning System |
CR Bard Inc. |
Shirin Mate |
| K173710 |
02/12/2018 |
MotoBAND CP Implant System |
CrossRoads Extremity Systems, LLC |
Chad Hollis |
| K180820 |
12/14/2018 |
Tono Vue Non-Contact Tonometer |
Crystalvue Medical Corporation |
Oliver Lin |
| K173185 |
02/14/2018 |
SEURATÖ Universal Pedicle Screw System |
CTL Medical Corporation |
Tosan Onosode |
| K180797 |
12/14/2018 |
Xcess Guiding Catheter |
Curatia Medical Co. |
Jessica Chiu |
| K181589 |
12/20/2018 |
Curiteva Lumbar Interbody Fusion System |
Curiteva, LLC |
Eric Linder |
| K182997 |
12/12/2018 |
enlighten III Laser System |
Cutera, Inc. |
Julia Brown |
| K173199 |
02/07/2018 |
PicoSure Workstation |
Cynosure, Inc |
Avinash Purohit |
| DEN170070 |
12/21/2018 |
MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /M |
Cytocell Ltd |
Xavier Baker |
| K162727 |
02/08/2018 |
SENYINT Remote Consultation System |
Dalian Senyint Digital Medical System Co., Ltd. |
Yinghui Miao |
| K170540 |
02/23/2018 |
DM-Density |
Densitas, Inc. |
Mo Abdolell |
| K180859 |
12/13/2018 |
PYRAMIDION Dental Implants and Prostheses |
DenTack Implants Ltd |
Tali Hazan |
| K180657 |
12/07/2018 |
Resin for Temporary Crown & Bridge |
Dentis Co., Ltd. |
Dong-Hun Jang |
| K182422 |
12/18/2018 |
Lucitone Denture Base Materials |
Dentsply Sirona |
Karl Nittinger |
| K182783 |
12/26/2018 |
DePuy Synthes Trauma Orthopedic Nail Implants |
DePuy Synthes |
Elizabeth Jacobs |
| K181231 |
12/06/2018 |
DePuy Synthes T-PAL Spacer System |
DePuy Synthes Spine |
Heta Shah |
| K182150 |
12/18/2018 |
Devon 52 Sequential Compression Device |
Devon Medical Products (Jiangsu) Ltd |
Neil Cheng |
| K173528 |
02/06/2018 |
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System |
Devon Medical Products (Jiangsu) Ltd. |
Julian Chu |
| K171521 |
02/16/2018 |
DUS R-50S (Urine Chemistry system) |
DFI Co., Ltd. |
Bella Cho |
| K173683 |
02/27/2018 |
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers |
DiaSorin Inc. |
John C Walter |
| K182698 |
12/26/2018 |
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device |
DiaSorin Inc. |
John C. Walter |
| K183223 |
12/19/2018 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K181037 |
12/21/2018 |
DIO CAD/CAM Abutment |
DIO Corporation |
Jiae Park |
| K182194 |
12/14/2018 |
UV Active Implant System |
DIO Corporation |
Park Jiae |
| K173048 |
12/06/2018 |
No-contact Forehead Thermometer |
Dongguan SIMZO Electronic Technology Co.Ltd. |
Mei Mei |
| K172828 |
02/01/2018 |
Double Medical Cage System |
Double Medical Technology Inc |
Yan Zuo |
| K172284 |
02/09/2018 |
NAPA LP-15 Airway Pressure Monitor |
DRW Medical, LLC |
Dan Tatum |
| K173644 |
02/15/2018 |
Gazelle Polypropylene Suture and Delivery Device |
Dura Tap LLC |
Ann R. Lee |
| K173335 |
02/08/2018 |
Gazelle PTFE and Suture Delivery Device |
Dura Tap LLC |
Ann R. Lee |
| K180380 |
12/21/2018 |
vital signs monitor |
Edan Instruments, Inc. |
Alice Yang |
| K172423 |
02/20/2018 |
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) |
Edwards Lifescience LLC |
Bedalin T. Lugo Rodriguez |
| K181498 |
12/10/2018 |
X-ray Imaging System for the McLaren Proton Treatment System |
EhmetDx, LLC |
Daniel Schoettlin |
| K180193 |
02/21/2018 |
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) |
El.En Electronic Engineering S.p.A. |
Paolo Peruzzi |
| K173791 |
02/09/2018 |
Leksell GammaPlan |
Elekta Instrument AB |
Matilda Forsberg |
| K182076 |
12/04/2018 |
Elekta Unity |
Elekta Limited |
Nicholas Power |
| K183037 |
12/04/2018 |
Monaco RTP System |
Elekta, Inc |
Kathryn Stinson |
| K183034 |
12/04/2018 |
MOSAIQ Oncology Information System |
Elekta, Inc |
Faiza Ahmed |
| K183012 |
12/21/2018 |
vascuCAP |
Elucid Bioimaging Inc. |
Andrew Buckler |
| K173783 |
12/14/2018 |
SCIg60 Infusion System |
EMED Technologies Corporation |
Peter Kollings |
| K181861 |
12/20/2018 |
Embrace |
Empatica Srl |
Simone Tognetti |
| K173587 |
02/16/2018 |
Magseed Magnetic Marker Systtem |
Endomagnetics Ltd. |
Andrew Shawcross |
| K183191 |
12/04/2018 |
6420 Ultrasound System |
Esaote, S.p.A. |
Massimo Polignano |
| K173315 |
02/13/2018 |
SupaChair Powered Wheelchair |
Eurogreen International Inc. |
David Hsieh |
| K173313 |
02/13/2018 |
SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP |
Eurogreen International Inc. |
David Hsieh |
| K173186 |
02/28/2018 |
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K173863 |
02/23/2018 |
Ez3D-i /E3 |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K182680 |
12/06/2018 |
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing |
Exciton Technologies, Inc. |
Melanie Ussyk |
| K183123 |
12/20/2018 |
microTargeting Guideline 4000 5.0 System |
FHC, Inc. |
Kelly Moeykens |
| K181690 |
12/21/2018 |
Clear-Jet Injection Catheter |
Finemedix Co. Ltd. |
Hee Kyung Kwon |
| K180082 |
02/11/2018 |
geko T-2 and geko Plus R-2 |
Firstkind Ltd |
Neil Buckley |
| K162553 |
12/20/2018 |
AirSpiral Heated Breathing Tube |
FISHER & PAYKEL HEALTHCARE |
STEPHANIE ELVIN |
| K181583 |
12/07/2018 |
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Si |
Flexicare Medical Limited |
Joel Biddle |
| K183307 |
12/11/2018 |
Magma Spark Pro (Magma Spark Plus, Alpha) |
Formatk Systems Ltd. |
Amit Goren |
| K183059 |
12/21/2018 |
3nethra neo |
Forus Health Pvt. Ltd. |
Shruti Kashinath |
| K180831 |
12/10/2018 |
CATSmart |
Fresenius Kabi AG |
Barry G. Hicks |
| K180615 |
12/04/2018 |
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter |
Fresenius Kabi USA LLC |
Kim Forch |
| K173651 |
02/14/2018 |
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K182419 |
12/14/2018 |
Centricity Universal Viewer |
GE Healthcare |
Renee Webb |
| K183116 |
12/06/2018 |
Unity Network ID |
GE Healthcare |
Brandon O'Shea |
| K182750 |
12/21/2018 |
4D View |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K181727 |
12/06/2018 |
Vivid iq |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K181663 |
12/20/2018 |
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel |
GenMark Diagnostics, Incorporated |
Alan Maderazo |
| K182690 |
12/21/2018 |
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel |
GenMark Diagnostics, Incorporated |
Beth Stofka |
| K172180 |
02/09/2018 |
OSCAR 15 |
Genoray Co.,Ltd |
Ji-Yeon Choi |
| K180679 |
12/07/2018 |
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Conc |
Global Scientific Technologies, LLC |
William J. Griswold, Jr. |
| K181357 |
12/06/2018 |
PATRIOT« Lumbar Spacers, SUSTAIN« Spacers |
Globus Medical Inc. |
Kelly Baker |
| K180909 |
12/18/2018 |
REVEL Spacers |
Globus Medical Inc. |
Kelly J. Baker |
| K171450 |
02/02/2018 |
Glooko Mobile Insulin Dosing System |
Glooko, Inc |
Tejasvi Pasi |
| K172750 |
02/28/2018 |
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) |
Guangzhou Sonostar Technologies Co., Ltd. |
Weizhong Cai |
| K182701 |
12/03/2018 |
Wondfo T-Cup Multi-Drug Urine Test Cup |
Guangzhou Wondfo Biotech Co., Ltd. |
Bin Chen |
| K181087 |
12/18/2018 |
Apex Locator, DPEX III |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K183068 |
12/21/2018 |
Nitrile Glove Powder Free White |
Haining Medical Products Co., Ltd. |
Zhiming Yao |
| K180255 |
02/28/2018 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
Zheng Shujian |
| K182068 |
12/13/2018 |
Erran Dental Zirconia |
Hangzhou Erran Technology Co., Ltd. |
Tingkai Li |
| K172870 |
02/13/2018 |
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J |
Hangzhou Hua'an medical&health instruments Co.,Ltd |
Ahneo Yang |
| K171568 |
02/22/2018 |
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty |
Hans Biomed Corporation |
Lucy Choi |
| K180578 |
12/12/2018 |
Harvest Dental Polymer Blocks |
Harvest Dental Products, LLC |
Sasha Der Avanessian |
| K182035 |
12/06/2018 |
FFRct |
HeartFlow, Inc |
Windi Hary |
| K173739 |
02/28/2018 |
ALOKA ARIETTA 850 |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K183253 |
12/18/2018 |
ValPro 2 Plus, VaPro 2 Plus Pocket |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K182006 |
12/06/2018 |
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths |
Hologic, Inc |
Rachelle D. Fitzgerald |
| K181294 |
12/14/2018 |
Honda Walking Assist Device |
Honda Motor Company, Ltd. |
Kazushi Hamaya |
| K170866 |
02/21/2018 |
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 |
Honsun(Nantong)Co.,Ltd |
Selina Qian |
| K171825 |
02/13/2018 |
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument |
Hunan Handlike Minimally Invasive Surgery Co., Ltd |
Hu hanhan |
| K182479 |
12/04/2018 |
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus |
Hycor Biomedical |
Tara Viviani |
| K182373 |
12/06/2018 |
PowerLook Tomo Detection V2 Software |
iCAD Inc. |
John DeLucia |
| K182167 |
12/21/2018 |
The ICHOR Panacea Vascular Embolectomy Catheter System |
ICHOR Vascular, Inc. |
Jeff Blair |
| K180670 |
12/07/2018 |
ICONN Campbell Interference Screw |
ICONN Orthopedics, LLC |
Whitt Israel |
| K180036 |
02/02/2018 |
SMAXEL CO2 Surgical Laser System |
IDS, LTD. |
Kwang Yeong Ahn |
| K183145 |
12/13/2018 |
IlluminOss Photodynamic Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K173083 |
12/03/2018 |
IMPLANTER DENTAL PLANNING SOFTWARE |
Implanter LLC |
Jorge Millan |
| K171516 |
02/05/2018 |
Flip Lube |
Imquest Biosciences Inc. |
Karen W. Buckheit |
| K173491 |
02/23/2018 |
RTS Lesser MTP Implant System |
In2Bones USA, LLC |
Rebecca Wahl |
| K183198 |
12/17/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordan |
| K173672 |
02/05/2018 |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter |
Inari Medical |
Eben Gordon |
| K173677 |
02/23/2018 |
InMode VLaze |
InMode MD Ltd. |
Amit Goren |
| K181703 |
12/28/2018 |
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments |
Institut Straumann AG |
Viviana Horhoiu |
| K171649 |
02/22/2018 |
Straumann CARES M-Series CAD/CAM System |
Institut Straumann AG |
Andreas Petermann |
| K182809 |
12/07/2018 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
MaryBeth Carson |
| K173567 |
02/14/2018 |
Sera |
Interacoustics A/S |
Amy Yanta |
| K170112 |
02/02/2018 |
IMD's Lumbar Puncture Needle |
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) |
WALTER ZOHMANN |
| K183107 |
12/11/2018 |
Intuitive Surgical Vessel Sealer Extend |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K182946 |
12/11/2018 |
Invacare TDX SP2-HD with Captain's Seat |
Invacare Corporation |
Elijah Wreh |
| K182900 |
12/14/2018 |
3880 MRI Patient Monitoring System |
Iradimed Corporation |
Francis X. Casey |
| K182130 |
12/27/2018 |
iSchemaView RAPID |
iSchemaView, Inc. |
Jim Rosa |
| K181374 |
12/14/2018 |
NRFit Syringe |
Jiangsu Caina Medical Co., Ltd |
Jun Lu |
| K173228 |
02/20/2018 |
U-MED Powder Free Polyethylene Examination Gloves,Blue Color |
Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. |
Chen Ye |
| K171535 |
02/15/2018 |
SURGICAL ISOLATION GOWN |
Jingzhou Haixin Green Cross Medical Products Co., Ltd |
Rarda L |
| K173565 |
02/14/2018 |
Sunrise 6200, Sunrise 7200 |
JK-Holding GmbH |
Juergen Gerstenmeier |
| K173553 |
02/08/2018 |
LUCAS 3 Chest Compression System |
Jolife AB |
Malin Melander |
| K181331 |
12/21/2018 |
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White |
Juvora, Ltd. |
Tim Leyva |
| K172941 |
02/12/2018 |
CASCADIA Interbody System |
K2M |
Nancy Giezen |
| K182473 |
12/12/2018 |
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems |
K2M Inc. |
Nancy Giezen |
| K171402 |
02/02/2018 |
KARL STORZ Slim Nasopharyngolaryngoscope |
KARL STORZ Endoscopy-America, Inc. |
AnnaLisa Smullin |
| K173320 |
02/23/2018 |
KLS Martin L1 MMF System |
KLS Martin LP |
Jennifer Damato |
| K182688 |
12/18/2018 |
SKR 3000 |
KONICA MINOLTA, INC. |
Tsutomu Fukui |
| K180084 |
02/08/2018 |
Ultrasound System SONIMAGE MX1 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K171171 |
02/22/2018 |
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) |
Koon Seng Sdn. Bhd. |
Koon Seng Sdn. Bhd. |
| K181958 |
12/06/2018 |
MagnetOs Putty |
Kuros Biosciences B.V. |
Yvonne P. Bovell |
| K183168 |
12/11/2018 |
OpenLoc-L Spinal Fixation System |
L&K Biomed Co., Ltd. |
Jihyeon Seo |
| K183348 |
12/17/2018 |
Reusable Silicone Cover CPRmeter 2 |
Laerdal Medical AS |
Mari Kaada |
| K182045 |
12/27/2018 |
Lotus III Multi-Pulsed Er: Yag Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K183102 |
12/07/2018 |
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody |
Leica Biosystems Newcastle Limited |
Jeremy Allen |
| K183100 |
12/07/2018 |
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 |
| K182795 |
12/21/2018 |
LENSAR Laser System - fs 3D (LLS-fs 3D) |
Lensar, Inc. |
Keith Peck |
| K173443 |
02/01/2018 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
Donna Gasper |
| K183286 |
12/07/2018 |
17HK701G-W |
LG Electronics Inc. |
Jinhwan Jun |
| K181625 |
12/11/2018 |
Life Spine ResoluteÖ Threaded Cage System |
Life Spine Inc. |
Angela Batke |
| K172105 |
02/02/2018 |
The Plateau-LO Spacer System |
Life Spine Inc. |
Randy Lewis |
| K173047 |
02/01/2018 |
The Solstice OCT System |
Life Spine, Inc. |
Randy Lewis |
| K182099 |
12/26/2018 |
Delta TT Pro |
Limacorporate S.p.A. |
Roberto Gabetta |
| K181159 |
12/03/2018 |
LZI Fentanyl Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K182354 |
12/14/2018 |
SafeAir Telescopic Smoke Pencil |
LiNA Medical ApS |
Natalia Szychulska |
| K173817 |
02/28/2018 |
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K183115 |
12/20/2018 |
MTS Levofloxacin 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K182922 |
12/14/2018 |
MTS Omadacycline 0.002-32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K173067 |
02/22/2018 |
LightForce LTS Model 1000, 1500, 2500, and 4000 |
LiteCure, LLC |
Eric Rock |
| K180945 |
12/10/2018 |
LUTRONIC GENIUS Radiofrequency System |
Lutronic Corporation |
Jhung Won Vojir |
| K172146 |
02/01/2018 |
MERISTEEL |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K182434 |
12/13/2018 |
LaparoGuard |
Mariner Endosurgery Inc. |
Mitch Wilson |
| K170175 |
02/26/2018 |
ENDOSEAL MTA |
MARUCHI |
Jang Sung Wook |
| K173805 |
02/08/2018 |
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Ti |
Marvao Medical Devices, Ltd. |
Christopher Davey |
| K173445 |
02/02/2018 |
Materialise TKA Guide System |
Materialise NV |
Oliver Clemens |
| K181826 |
12/10/2018 |
Glenoid Polyaxial Non-locking Screws |
Medacta International SA |
Stefano Baj |
| K181970 |
12/04/2018 |
MectaLIF Posterior Extension |
Medacta International SA |
Stefano Baj |
| K180242 |
02/28/2018 |
HeRO Symphony, HeRO ES, HeRO solo/duet |
Medical Predictive Science Corporation |
Will King |
| K180091 |
02/08/2018 |
UNiD Spine Analyzer |
Medicrea International |
David Ryan |
| K172541 |
02/22/2018 |
Medline Catheter Specimen Collector |
Medline Industries, Inc. |
Dinah Rincones |
| K182812 |
12/12/2018 |
Medline Cautery Electrode (SILICONE) |
Medline Industries, Inc. |
Matt Clausen |
| K173537 |
02/08/2018 |
CONCORDE LIFTÖ |
Medos International, SARL |
Karen Sylvia |
| K182610 |
12/19/2018 |
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device |
Medtronic |
Kari Christianson |
| K173460 |
02/16/2018 |
NeuroEEG |
MemoryMD Inc. |
Abdus-Salaam Muwwakkil |
| K180004 |
02/22/2018 |
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens |
Menicon Co., Ltd. |
Kenichi Tanaka |
| K173750 |
02/15/2018 |
Prelude IDeal Hydrophilic Sheath Introducer |
Merit Medical Systems, Inc. |
David Thomas |
| K171641 |
02/06/2018 |
Accula Flu A/Flu B Test |
Mesa Biotech, Inc. |
Barbara E. Stevens |
| K182242 |
12/26/2018 |
VO200 û NeurOs Cerebral Oximetry System |
Mespere LifeSciences Inc. |
Rebecca S. Li |
| K180772 |
12/17/2018 |
Met One Czar Anterior Cervical Plate System |
Met One Technologies |
Evan Carbonell |
| K182810 |
12/10/2018 |
Distal Radius Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K183185 |
12/18/2018 |
Riptide Aspiration System (Riptide Large Bore Aspiration System) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Nancy Drew |
| K182556 |
12/14/2018 |
SureClip Repositionable Hemostasis Clip |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K173963 |
02/21/2018 |
DRI Benzodiazepine Assay |
Microgenics Corporation |
Minoti Patel |
| K173195 |
02/13/2018 |
DRI Hydrocodone Assay |
Microgenics Corporation |
Minoti Patel |
| K171384 |
02/01/2018 |
Micromed BRAIN QUICK system |
Micromed S.P.A |
Monica Camillo |
| K182125 |
12/06/2018 |
EVOLUTION Stemmed CS Femur |
MicroPort Orthopedics Inc. |
Hunter Ethan Williams |
| K182624 |
12/18/2018 |
MIM - MRT Dosimetry |
MIM Software Inc. |
Lynn Hanigan |
| K182207 |
12/14/2018 |
TR90BH |
MinXray, Inc |
Keith Kretchmer |
| K182016 |
12/06/2018 |
Simplicit90Y |
Mirada Medical Ltd. |
Sarah Bond |
| DEN180007 |
12/21/2018 |
Miris Human Milk Analyzer |
Miris AB |
Elin Hallen |
| K182989 |
12/18/2018 |
AURORAÖ Screw System |
MiRus, LLC |
Jordan Bauman |
| K173512 |
02/05/2018 |
MFI-Cardiac |
MultiFunctional Imaging, LLC |
Dan Kadrmas |
| K173763 |
02/28/2018 |
iovera system |
Myoscience, Inc |
Kent Jones |
| K173580 |
02/15/2018 |
Vinyl Patient Examination Glove (Yellow) |
Nature Medical Products Co.,Ltd. |
Chao Kevin |
| K180828 |
12/20/2018 |
Natureplex Warm Touch Warming Jelly |
Natureplex, LLC |
Pamela Hopkins |
| K182178 |
12/13/2018 |
neoBLUE blanket LED Phototherapy System |
Natus Medical Incorporated |
Judy Buckham |
| K180181 |
02/22/2018 |
Natus Quantum |
Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) |
Sanjay Mehta |
| K172422 |
02/09/2018 |
Kohli Urinary Drainage Catheter |
Nellie Medical, LLC |
Ronald Adams |
| K173450 |
02/07/2018 |
PRESS DUO elite, PRESS DUO elite AG |
Nemoto Kyorindo Co., Ltd. |
Jim Knipfer |
| K173402 |
02/22/2018 |
Neocis Guidance System (NGS) with Chairside Splint |
Neocis Inc |
Alon Mozes |
| K182776 |
12/21/2018 |
Neocis Guidance System |
Neocis Inc. |
Thomas E. Claiborne |
| K173409 |
02/16/2018 |
Wireless Audio System |
NeoCoil, LLC |
Michael Leigh |
| K173077 |
02/23/2018 |
Cavetto-SA Cervical Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K172320 |
02/26/2018 |
Neurostructures Cavetto« Cervical Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K172208 |
02/16/2018 |
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet |
NeVap, Inc. |
Brenton Hanlon |
| K173746 |
02/27/2018 |
Activmotion Range |
Newclip Technics |
Gaelle LUSSORI |
| K181695 |
12/07/2018 |
Nihon Kohden NKV-550 Series Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Sheryl Higgins |
| K183069 |
12/04/2018 |
NobelZygoma 0░ |
Nobel Biocare AB |
Charlemagne Chua |
| K181869 |
12/12/2018 |
On1 Universal Abutment |
Nobel Biocare AB |
Charlemagne Chua |
| K180123 |
02/16/2018 |
Breast BI 7 MR Coil 1.5T Mammavention |
Noras MRI products GmbH |
Jens Heidenmann |
| K183169 |
12/27/2018 |
Pulse 2.0, Pulse Pro 2.0 |
NormaTec Industries, LP |
Albert G. Sanford |
| K183328 |
12/21/2018 |
Pulse Rx 2.0, Pulse Pro Rx 2.0 |
NormaTec Industries, LP |
Albert G. Sanford |
| K173036 |
12/21/2018 |
North-vision Multi-parameter Patient Monitor |
North-vision Tech. Inc. |
Albert Huang |
| K182549 |
12/13/2018 |
StatStrip Xpress 2 Glucose Hospital Meter System |
Nova Biomedical Corporation |
Khushboo Surendran |
| K182552 |
12/13/2018 |
StatStrip Xpress Glucose Hospital Meter System |
Nova Biomedical Corporation |
Khushboo Surendran |
| K173236 |
02/22/2018 |
Sentry IVC Filter |
Novate Medical Ltd. |
Gordon Crowley |
| K182387 |
12/17/2018 |
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) |
Novo Nordisk Inc. |
Elizabeth D'Amato |
| K173025 |
02/08/2018 |
NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System |
NuVasive, Incorporated |
Cynthia Adams |
| K182949 |
12/04/2018 |
HealixÖ Compression Screw System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K180237 |
02/27/2018 |
Rezum System |
NxThera, Inc. |
Kathy Simpson |
| K182454 |
12/20/2018 |
O2 Concepts Oxlife Independence Model 301-0001 |
O2 Concepts LLC |
Kathryn G. Forgione |
| DEN170091 |
12/28/2018 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| K171755 |
02/09/2018 |
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System |
Omega Medical Imaging, LLC |
John Newman |
| K180130 |
02/23/2018 |
ELEOSÖ Bipolar Acetabular System |
Onkos Surgical, Inc. |
Jan Triani |
| K173707 |
02/28/2018 |
P200TE |
Optos plc |
Geoff Fatzinger |
| K173894 |
02/09/2018 |
Jade PTA Balloon Dilatation Catheter |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K172698 |
02/07/2018 |
G-Beam Fusion Beaming System |
Orthofix Srl |
Gianluca Ricadona |
| K173255 |
02/22/2018 |
Talon DistalFix Humeral Nail |
Orthopedic Designs North America, Inc. |
Robin Wilson |
| K173693 |
02/23/2018 |
Orbitum Bone Staple Implant, X and VI |
Orthovestments, LLC |
Robert Weinstein |
| K183267 |
12/20/2018 |
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 |
| K173967 |
02/22/2018 |
Remedy Acetabular Cup |
Osteoremedies LLC |
Chris Hughes |
| K171576 |
02/22/2018 |
The Panthera Anti-Snoring X3 Device |
Panthera Dental Inc. |
Martine Fortin |
| K182296 |
12/14/2018 |
HyperFil-LV |
Parkell, Inc. |
David Mott |
| K173681 |
12/10/2018 |
reSET-O |
Pear Therapeutics, Inc. |
Yuri Maricich |
| K161222 |
02/07/2018 |
PENTAX MEDICAL ED-3490TK, Video Duodenoscope |
PENTAX MEDICAL |
KANCHANA IYER |
| K182747 |
12/18/2018 |
EliA RF IgM Immunoassay |
Phadia AB |
Carina Magnusson |
| K183007 |
12/24/2018 |
EliA SmDP Immunoassay |
Phadia AB |
Carina Magnusson |
| K182926 |
12/06/2018 |
IntelliSpace Radiology |
Philips Healthcare Informatics, Inc. |
Paige Gridack |
| K173433 |
02/05/2018 |
ProxiDiagnost N90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K183101 |
12/31/2018 |
Zenition 50 |
Philips Medical Systems Nederland BV |
Sumit Kumar |
| K183040 |
12/06/2018 |
Zenition 70 |
Philips Medical Systems Nederland BV |
Sumit Kumar |
| K173729 |
02/28/2018 |
REVIAN RED |
PhotonMD, Inc |
William A Knape |
| K181825 |
12/04/2018 |
CAAS MR Solutions |
Pie Medical Imaging B.V. |
Annemiek Bouts |
| K182781 |
12/21/2018 |
PTS Professional Chemistry Kit |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
Samuel Engelman |
| K171403 |
02/02/2018 |
OralTox Oral Fluid Drug Test |
Premier Biotech Inc |
Jacqueline Gale |
| K172934 |
02/16/2018 |
Needle Free Transseptal Cannula |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K172950 |
02/21/2018 |
TSN Transseptal Needle |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| K182670 |
12/20/2018 |
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S. Bagga |
| K171620 |
02/21/2018 |
PiCCO Catheter |
PULSION Medical Systems SE |
Ingrid Rohm |
| K183111 |
12/07/2018 |
Contour 24 |
Quality Electrodynamics, LLC |
Eric Yeh |
| K180158 |
02/14/2018 |
Surgical Laser fibers |
Quanta System SPA |
Francesco Dell'Antonio |
| K182564 |
12/27/2018 |
Quantib ND |
Quantib BV |
Floor van Leeuwen |
| K180288 |
02/13/2018 |
QuickVue Influenza A+B |
Quidel Corporation |
Jennifer S. Rial |
| K173691 |
02/28/2018 |
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack |
Quidel Corporation |
Jennifer S. Rial |
| K163601 |
12/06/2018 |
RII Smart IR Thermometer |
RADIANT INNOVATION INC. |
Monica Chung |
| K182668 |
12/14/2018 |
Rapid Reboot Compression Therapy System |
Rapid Reboot Recovery Products, LLC |
David Johnson |
| K182805 |
12/14/2018 |
RCT800 |
RAY Co., Ltd |
Changhwan Lee |
| K182007 |
12/07/2018 |
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System |
Renovis Surgical Technologies |
Anthony DeBenedictis |
| K172647 |
02/21/2018 |
Reprocessed ArthroCare ENT Coblator |
ReNovo, Inc. |
Mark K. Wells |
| K172751 |
02/09/2018 |
iVitri Straw |
Reprobitech Corp. |
Huai L. Feng |
| K181372 |
12/13/2018 |
Argos |
Retia Medical, LLC |
Marc Zemel |
| K180999 |
12/11/2018 |
Mygen V-1000 RF System |
RF Medical Co., Ltd |
Kwang S. Choi |
| K181269 |
12/14/2018 |
iCertainty |
Rfpi |
Jeffery Basham |
| K181131 |
12/13/2018 |
Accu-Chek Guide Me Blood Glucose Monitoring System |
Roche Diabetes Care |
Ginger Emrich |
| K171605 |
02/20/2018 |
Elecsys CA 15-3 II |
Roche Diagnostics |
Adennis Cora |
| K182512 |
12/10/2018 |
Route 92 Medical Delivery Catheter |
Route 92 Medical Inc. |
Kathy Tansey |
| K182183 |
12/07/2018 |
GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A |
Samsung Electronics Co., LTD. |
Jaesang Noh |
| K173204 |
02/05/2018 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
Ji Yea Lee |
| K182595 |
12/18/2018 |
HERA W10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K181336 |
12/04/2018 |
HS50 / HS60 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K173513 |
02/20/2018 |
WS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K173882 |
02/06/2018 |
SeaSpine Mariner Pedicle Screw System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K180176 |
02/20/2018 |
SeaSpine NewPort Spinal System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173334 |
02/22/2018 |
SeaSpine Spinous Process System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K182905 |
12/14/2018 |
UniPulse |
Seaward Group |
Jim Wallace |
| K180762 |
12/14/2018 |
CAPI 3 HEMOGLOBIN(E) |
SEBIA |
Karen Anderson |
| K171861 |
02/07/2018 |
CAPILLARYS Hb A1c |
Sebia |
Karen Anderson |
| K182001 |
12/17/2018 |
Acucy Influenza A&B Test with the Acucy System |
Sekisui Diagnostics, LLC |
Shelly Harris |
| K172839 |
02/13/2018 |
ENDOSOLV |
Septodont |
Jaimie Woodruff |
| K181744 |
12/11/2018 |
BI-MENTUM dual mobility system |
Serf |
Jean-Lus Aurelle |
| K182938 |
12/18/2018 |
Emission Computed Tomography System |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K180878 |
12/17/2018 |
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Tes |
Shanghai Venture Bio-Tech CO., Ltd. |
Longli Long |
| K180879 |
12/14/2018 |
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use |
SHANGHAI VENTURE BIO-TECH CO., LTD. |
Longli Long |
| K182190 |
12/19/2018 |
Fetal Doppler |
Shenzhen AOJ Medical Technology Co., Ltd. |
Qihuan Zhao |
| K182755 |
12/21/2018 |
Disposable Temperature Probe |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K182433 |
12/17/2018 |
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K172797 |
02/28/2018 |
ECG Cable/Leadwires |
Shenzhen Coreray Technology., Ltd |
Simon Fan |
| K181967 |
12/10/2018 |
Disposable Temperature Probe |
Shenzhen Launch Electrical Co., LTD |
Jiaan Huang |
| K172883 |
02/12/2018 |
Home Use Hair Removal Device/T1, T2, T3 |
Shenzhen Mareal Tech Co., Ltd |
Libin Liu |
| K182075 |
12/10/2018 |
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K172897 |
12/07/2018 |
Neck Care Therapy, Model: SYK 509B |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K182165 |
12/20/2018 |
Color Doppler Ultrasound System; Model: mEye1 and mEye2 |
Shenzhen Well.D Medical Electronics Co., LTD. |
Ning Bai |
| K181496 |
12/18/2018 |
VINTAGE PRO |
Shofu Dental Corporation |
Mauro Malzyner |
| K180039 |
02/01/2018 |
ACUSON Juniper Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K173957 |
02/01/2018 |
ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K180067 |
02/07/2018 |
ACUSON X800 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| K173592 |
02/13/2018 |
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K173981 |
02/02/2018 |
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. Ultrasound Group |
Sulgue Choi |
| K172832 |
02/06/2018 |
Insight BD |
Siemens Medical Solutions, Inc |
Denise Adams |
| K180754 |
12/07/2018 |
C-Zero Pedicle Screw System, Freedom Pedicle Screw System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K181899 |
12/13/2018 |
ROCCIA« PLIF |
Silony Medical GmbH |
Bircan Tasdelen |
| K173747 |
12/21/2018 |
REXLENE |
SM ENG CO., LTD |
Soon-Gu Lee |
| K172005 |
02/02/2018 |
PICO 7 Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K172395 |
02/01/2018 |
Duatene bilayer mesh |
Sofradim Production |
Benjamin Rochette |
| K182146 |
12/03/2018 |
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set |
Sol-Millennium Medical, Inc. |
James Barley |
| K172160 |
02/09/2018 |
Southern Implants PEEK Abutments |
Southern Implants (Pty) Ltd |
Lauranda Breytenbach |
| K173343 |
02/27/2018 |
Zygomatic Implant System |
Southern Implants (Pty) Ltd |
Lauranda G. Breytenbach |
| K180653 |
12/04/2018 |
Spartan eCoil System |
Spartan Micro, Inc |
Mark Dias |
| K182584 |
12/10/2018 |
Lucent« XP |
Spinal Elements Inc |
Cheryl Allen |
| K182954 |
12/12/2018 |
SalvoÖ Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K171797 |
02/26/2018 |
TRYPTIK2 C-Plate Anterior Cervical Plate System |
Spineart |
Franck Pennesi |
| K173224 |
02/23/2018 |
SPIN-SWI |
SpinTech, Inc. |
Kay Fuller |
| K180141 |
02/16/2018 |
SPIWay Endonasal Access Guide |
SPIWay, LLC |
Eugene Chen |
| K171287 |
02/01/2018 |
Sporview VH202 BI |
SPSmedical Supply Corp. A Division of Cantel Medical |
Brent Geiger |
| K181865 |
12/14/2018 |
Acu-sInQ Complete Endoscope Cleaning Aid System |
STERIS Corporation |
Gregory Land |
| K173493 |
02/23/2018 |
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 |
STERIS Corporation |
Anthony Piotrkowski |
| K173485 |
02/22/2018 |
Amsco Evolution Medium Steam Sterilizer |
STERIS Corporation |
Anthony Piotrkowski |
| K173490 |
02/22/2018 |
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) |
STERIS Corporation |
Anthony Piotrkowski |
| K172752 |
02/09/2018 |
CELERITY 20 HP Biological Indicator |
Steris Corporation |
Jennifer Nalepka |
| K173634 |
02/12/2018 |
CELERITY 20 Steam Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K173670 |
02/12/2018 |
CELERITY 20 Steam Incubator |
STERIS Corporation |
Anthony Piotrkowski |
| K173626 |
02/21/2018 |
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles |
STERIS Corporation |
Anthony Piotrkowski |
| K173629 |
02/21/2018 |
CELERITY 20 Steam Process Challenge Device for Gravity Cycles |
STERIS Corporation |
Anthony Piotrkowski |
| K182724 |
12/10/2018 |
CelerityTM 10 STEAM Chemical Indicator |
STERIS Corporation |
Eileen McCafferty |
| K172755 |
02/09/2018 |
PRO-LITE Sterilization Trays |
Steris Corporation |
Tricia Cregger |
| K172754 |
02/09/2018 |
V-PRO maX 2 Low Temperature Sterilization System |
Steris Corporation |
Bill Brodbeck |
| K173633 |
02/28/2018 |
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag |
Steris Corporation |
Jennifer Nalepka |
| K172753 |
02/09/2018 |
VERIFY VH2O2 Indicator Tape |
Steris Corporation |
Bill Brodbeck |
| K172746 |
02/09/2018 |
VERIFY« HPU Chemical Indicator and VERIFY« Vaporized VH2O2 Process Indicator Adhesive Label |
STERIS Corporation |
Bill Brodbeck |
| K172749 |
02/09/2018 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
Steris Corporation |
Tricia Cregger |
| K172748 |
02/09/2018 |
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack |
STERIS Corporations |
Jennifer Nalepka |
| K171520 |
02/07/2018 |
SteriZign Signatur Device Protection System |
SteriZign Precision Technologies, LLC |
Sonia Lutarewych |
| K182359 |
12/13/2018 |
HipCheck |
Stryker Corp. |
Cara Mellits |
| K180327 |
02/26/2018 |
Stryker iVAS 13g Bone Biopsy Kit |
Stryker Corporation |
Kristi Ashton |
| K181752 |
12/21/2018 |
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) |
Stryker Corporation |
Kristi Ashton |
| K173849 |
02/02/2018 |
Triathlon Total Knee System |
Stryker Orthopaedics |
Margaret Crowe Klippel |
| K173823 |
02/09/2018 |
Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System |
Summit Industries LLC |
Tom Boon |
| K170793 |
02/12/2018 |
SuRgical Planner (SRP) |
Surgical Theater, LLC |
Kevin Murrock |
| K171869 |
02/23/2018 |
Sutter CURIS RF Generator |
Sutter Medizintechnik GmbH |
Ulrike Zeissler |
| K161989 |
02/01/2018 |
PREMIUM Implant Systems SHELTA Implant Systems |
SWEDEN & MARTINA S.p.A. |
Alessia Pezzato |
| K182438 |
12/06/2018 |
Synthetic Polyisoprene Lubricated Male Condom - 5 senses |
Sxwell Usa LLC |
Robert Mahler |
| K173272 |
02/09/2018 |
Ergonomic Handle |
Symmetry Surgical Inc. |
Christopher Smith |
| K172338 |
02/21/2018 |
Catasyn Advanced Technology Wound Hydrogel |
Synedgen, Inc |
Shenda Baker |
| K180821 |
12/21/2018 |
TruMatch Graft Cage - Long Bone |
Synthes (USA) LLC |
Christopher J. Medberry |
| K181675 |
12/10/2018 |
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System |
TaiDoc Technology Corporation |
Yvette Chang |
| K180863 |
12/19/2018 |
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator |
TaiDoc Technology Corporation |
Sylvia Liu |
| K182491 |
12/10/2018 |
Applanation tonometer AT-2 |
Takagi Seiko Co., Ltd. |
Shinya Kitamura |
| K170131 |
02/10/2018 |
TAV Medical Dental Implants System |
Tav Medical Ltd. |
Revital Shabtai |
| K182506 |
12/10/2018 |
LipiScan Dynamic Meibomian Imager |
TearScience, Inc. |
Christy Coleman |
| K172775 |
02/12/2018 |
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle |
Teleflex Medical, Inc. |
Holly Hallock |
| K173545 |
02/14/2018 |
TEMED Gas Diffuser |
TEMED |
Katie Evans |
| K172868 |
02/28/2018 |
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls |
The Binding Site Group Ltd. |
Kirsty Samuels |
| K172613 |
02/15/2018 |
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit |
The Binding Site Group Ltd. |
Andrea Thomas |
| K182736 |
12/28/2018 |
OIC Suture Anchor System |
The Orthopaedic Implant Company |
Douglas Fulton |
| DEN170072 |
12/20/2018 |
Enlight 1810 |
Timpel Inc. |
Rafael Holzhacker |
| K182682 |
12/21/2018 |
OrthoGold 100 |
Tissue Regeneration Technologies |
John Warlick |
| K173535 |
02/13/2018 |
Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TAS Hyperlordotic Interbody Fusion Device and Endoskeleton« TCS Interbody Fusion Device |
Titan Spine, LLC |
Jane Rodd |
| K173275 |
02/27/2018 |
OMNICHROMA |
Tokuyama Dental Corporation |
Keith A. Barritt |
| K182461 |
12/27/2018 |
LATITUDE EV Total Elbow Arthroplasty |
Tornier Inc. |
Renee Stoffel |
| K172504 |
02/09/2018 |
Tosama Biobased Applicator Tube Menstrual Tampon |
TOSAMA, d.o.o. |
Marjetka Kralj Kuncic |
| K173468 |
02/23/2018 |
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173736 |
02/28/2018 |
TrackX |
TrackX Technology, LLC |
Calley Herzog |
| K180889 |
12/07/2018 |
Tractus Crossing Support Catheter |
Tractus Vascular LLC |
Janet Burpee |
| K183098 |
12/06/2018 |
Senhance Surgical System |
TransEnterix, Inc. |
Michele Jans |
| K173367 |
02/28/2018 |
MC 300* Nebulizer |
Trudell Medical International |
Marianne Tanton |
| K181612 |
12/17/2018 |
Tyto Stethoscope (OTC) |
Tyto Care Ltd. |
Stella Raizelman Perry |
| K183383 |
12/12/2018 |
ANAXÖ OCT Spinal System |
U & I Corporation |
Young Eun Lee |
| K181824 |
12/13/2018 |
CBT Screw Fixation System |
U&i Corporation |
Jee-Ae Bang |
| K171823 |
02/22/2018 |
U&U Indicator tape and strip |
U&U Medical Technology Co., Ltd |
Xuebo Wang |
| K173163 |
02/09/2018 |
ChlorCid, ChlorCid V, ChlorCid Surf |
Ultradent Products, Inc. |
Corey Jaseph |
| K183212 |
12/07/2018 |
Nexus DR Digital X-ray Imaging System with stitching |
Varex Imaging Corporation |
Michael Van Ryn |
| K171631 |
02/09/2018 |
Standard Catheter Set |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K173636 |
02/15/2018 |
Velocity |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K180128 |
02/16/2018 |
Warrior 14 guidewire |
Vascular Solutions, Inc |
Becky Astrup |
| K172509 |
02/01/2018 |
Sentosa SA201 HSV 1/2 Qualitative PCR Test |
Vela Diagnostics USA Inc. |
Donald Henton |
| K180175 |
12/07/2018 |
SignalMark Lung Biopsy Site Marker |
ViewPoint Medical, Inc. |
Thomas Kane |
| K171668 |
02/26/2018 |
Bluetooth blood pressure monitor |
Visiomed Group SA |
Eric Sebban |
| K172965 |
12/17/2018 |
Handheld VitalSigns Monitoring System |
Visiomed Technology Co.,Ltd |
Chen XiaoFeng |
| K180204 |
12/28/2018 |
CranioMaxillofacial Fixation (CMF) System - CMF Visionare |
Visionare LLC |
Mariane de Oliveira Quinzani |
| K171208 |
02/05/2018 |
Trans-anal Introducer |
Visionsense Ltd. |
Alex Chanin |
| K173140 |
12/19/2018 |
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitorin |
VivaChek Laboratories, Inc. |
Julie Zhou |
| DEN170073 |
02/13/2018 |
ContaCT |
Viz.Al, Inc. |
Gregory Ramina |
| K181877 |
12/17/2018 |
Phoenix 2.4mm Atherectomy Plus System |
Volcano AtheroMed Inc. |
Jean Chang |
| K182972 |
12/20/2018 |
Phoenix Atherectomy System |
Volcano AtheroMed Inc. |
Jean Chang |
| K180533 |
12/10/2018 |
Procellera Composite Antibacterial Wound Dressing |
Vomaris Wound Care, Inc. |
Charmaine Sutton |
| K172439 |
02/14/2018 |
Siberian Fit |
Vydence |
Kevin Walls |
| K172899 |
02/26/2018 |
Vygon PICCs |
Vygon USA |
Jillian Mikovich |
| K171695 |
02/05/2018 |
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana |
W.H.P.M., Inc. |
John Wan |
| K172040 |
02/05/2018 |
Aquilex Fluid Control System AQL-100S |
W.O.M. World Of Medicine GmbH |
Lucia Puetmann |
| K163377 |
02/21/2018 |
Captura Disposable Bronchoscope Biopsy Forceps |
Wilson-Cook Medical Inc. |
Ashley Howard |
| K172237 |
02/02/2018 |
Bicera Resorbable Bone Substitute |
Wiltrom Corporation Limited |
Yi-Chun Su |
| K171455 |
02/09/2018 |
AT-6XX Series Infrared Thermometer |
Xiamen Acurio Instruments Co., Ltd |
Angel Liu |
| K182038 |
12/10/2018 |
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer |
YD Diagnostics Corporation |
Hyuckjoo Lee |
| K173561 |
02/12/2018 |
Vinyl Patient Examination Glove (Yellow) |
Yurun Glove Co., Ltd. |
Chao Kevin |
| K181641 |
12/24/2018 |
QuikClot Radial |
Z-Medica, LLC |
Sheila K. Wallin |
| K181107 |
12/06/2018 |
Elevo« Kit Snoring Intervention Device |
Zelegent, Inc. |
David C. Humbert |
| K171495 |
02/12/2018 |
Zyston Strut Open Titanium Spacer System |
Zimmer Biomet Spine Inc. |
Megan Fessenden |
| K181827 |
12/14/2018 |
Affixus Natural Nail System Humeral Nail |
Zimmer GmbH |
Robert Tommasini |
| K182048 |
12/07/2018 |
Avenir Complete Hip System |
Zimmer, Inc |
Rebecca D Noftz |
| K181761 |
12/26/2018 |
Zimmer Biomet Select Ceramic Heads |
Zimmer, Inc |
Carol Vierling |
