Search FDA 510(k) Database

Cleared Aug 24, 2018

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER...

K173978 · DQK

Biosense Webster, Inc.

Cardiovascular · 238d

Cleared Aug 24, 2018

NC TREK™ RX Coronary Dilatation Catheter

K180040 · LOX

Abbott Vascular

Cardiovascular · 231d

Cleared Aug 24, 2018

Firebird® Spinal Fixation Systems: Firebird System

K180179 · NKB

Orthofix, Inc.

Orthopedic · 213d

Cleared Aug 24, 2018

CancelleX Porous Titanium Lumbar Interbody Device

K180373 · MAX

Xenco Medical, LLC

Orthopedic · 193d

Cleared Aug 24, 2018

APTUS CMC-I Fusion Plate System

K181009 · HRS

Medartis AG

Orthopedic · 129d

Cleared Aug 24, 2018

AOS Small Fragment Plating System Lite

K181035 · HRS

Advanced Orthopaedic Solutions, Inc....

Orthopedic · 128d

Cleared Aug 24, 2018

Solitaire 2 and Solitaire Platinum Revascularization Device

K181060 · POL

Medtronic Neurovascular

Neurology · 123d

Cleared Aug 24, 2018

NuVasive Brigade Lateral System

K181386 · OVD

Nu Vasive, Incorporated

Orthopedic · 91d

Cleared Aug 24, 2018

RadiForce GX560, GX560-AR

K181609 · PGY

Eizo Corporation

Radiology · 66d

Cleared Aug 24, 2018

EasyMax BT Self-Monitoring Blood Glucose System

K182057 · NBW

Eps Bio Technology Corp.

Chemistry · 24d

Cleared Aug 23, 2018

Z-CAD smile

K170050 · EIH

Metoxit AG

Dental · 595d

Cleared Aug 23, 2018

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

K173657 · EZL

Cook Incorporated

Gastroenterology & Urology · 267d

Cleared Aug 23, 2018

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

K173732 · DFH

The Binding Site Group , Ltd.

Immunology · 260d

Cleared Aug 23, 2018

Smylic Invisible Clear Aligners

K173784 · NXC

Smylio, Inc.

Dental · 253d

Cleared Aug 23, 2018

GMK Sphere - Kinematic Alignment

K173890 · JWH

Medacta International S.A.

Orthopedic · 245d

Cleared Aug 23, 2018

Freespira

K180173 · HCC

Palo Alto Health Sciences, Inc.

Neurology · 213d

Cleared Aug 23, 2018

Stat Profile Prime Plus Analyzer System

K180186 · GGZ

Nova Biomedical Corporation

Chemistry · 212d

Cleared Aug 23, 2018

ADVIA Centaur Herpes-1 IgG

K181333 · MXJ

Biokit, S.A.

Microbiology · 94d

Cleared Aug 23, 2018

ADVIA Centaur Herpes-2 IgG

K181334 · MYF

Biokit, S.A.

Microbiology · 94d

Cleared Aug 23, 2018

SpyGlass DS and DS II Direct Visualization System

K181439 · FBN

Boston Scientific Corporation

Gastroenterology & Urology · 83d

Cleared Aug 23, 2018

GMK Sphere CR Tibial Inserts

K181635 · JWH

Medacta International S.A.

Orthopedic · 63d

Cleared Aug 23, 2018

MyoSure XL Tissue Removal Device for Fluent

K181974 · HIH

Hologic, Inc.

Obstetrics & Gynecology · 30d

Cleared Aug 22, 2018

Non-invasive blood pressure measurement systems

K173024 · DXN

Joytech Healthcare Co. , Ltd.

Cardiovascular · 328d

Cleared Aug 22, 2018

NIM PAK Needle

K180542 · PDQ

Boston Endo Surgical Tech,

Neurology · 174d