Search FDA 510(k) Database

Cleared Dec 20, 2018

Reuter Tip Deflecting Wire Guide

K180830 · DQX

Cook Incorporated

Cardiovascular · 265d

Cleared Dec 20, 2018

Curiteva Lumbar Interbody Fusion System

K181589 · MAX

Curiteva, LLC

Orthopedic · 185d

Cleared Dec 20, 2018

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

K181663 · PAM

Genmark Diagnostics, Incorporated

Microbiology · 178d

Cleared Dec 20, 2018

Sinusway Dilation System

K181838 · LRC

3nt Medical , Ltd.

Ear, Nose, Throat · 163d

Cleared Dec 20, 2018

Embrace

K181861 · POS

Empatica S.R.L.

Neurology · 161d

Cleared Dec 20, 2018

Color Doppler Ultrasound System

K182165 · IYN

Shenzhen Well.D Medical Electronics...

Radiology · 132d

Cleared Dec 20, 2018

BD Contoured Base Pen Needle

K182320 · FMI

Becton, Dickinson and Company

General Hospital · 115d

Cleared Dec 20, 2018

ASAHI Corsair Pro XS

K182420 · DQY

Asahi Intecc Co., Ltd.

Cardiovascular · 106d

Cleared Dec 20, 2018

O2 Concepts Oxlife Independence Model 301-0001

K182454 · CAW

O2 Concepts, LLC

Anesthesiology · 104d

Cleared Dec 20, 2018

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute

K182670 · MQV

Prosidyan, Inc.

Orthopedic · 86d

Cleared Dec 20, 2018

Phoenix Atherectomy System

K182972 · MCW

Volcano Atheromed, Inc.

Cardiovascular · 55d

Cleared Dec 20, 2018

Dilator Sets

K183036 · DRE

Cook Incorporated

Cardiovascular · 49d

Cleared Dec 20, 2018

MTS Levofloxacin 0.002 - 32 µg/mL

K183115 · JWY

Liofilchem S. R. L.

Microbiology · 41d

Cleared Dec 20, 2018

microTargeting Guideline 4000 5.0 System

K183123 · GZL

FHC, Inc.

Neurology · 37d

Cleared Dec 20, 2018

DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction...

K183267 · DXT

Osprey Medical, Inc.

Cardiovascular · 27d

Cleared Dec 19, 2018

VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...

K173140 · NBW

Vivachek Laboratories, Inc.

Chemistry · 446d

Cleared Dec 19, 2018

Arterial Pressure Monitoring Set/Tray

K180846 · DQO

Cook Incorporated

Cardiovascular · 261d

Cleared Dec 19, 2018

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

K180863 · BTA

Taidoc Technology Corporation

Ear, Nose, Throat · 261d

Cleared Dec 19, 2018

Modified BrainScope One

K181785 · PIW

Brainscope Company, Inc.

Neurology · 169d

Cleared Dec 19, 2018

BA310 Abutment, BIA310 Implant/Abutment

K182116 · MAH

Cochlear Americas

Ear, Nose, Throat · 135d

Cleared Dec 19, 2018

FFRangio System

K182149 · QEK

Cathworks, Ltd.

Cardiovascular · 133d

Cleared Dec 19, 2018

Fetal Doppler

K182190 · KNG

Shenzhen AOJ Medical Technology Co.,...

Obstetrics & Gynecology · 128d

Cleared Dec 19, 2018

TruShot with Y-Knot All-Suture Anchor

K182446 · MBI

Conmed Corporation

Orthopedic · 103d

Cleared Dec 19, 2018

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation...

K182610 · OCL

Medtronic

Cardiovascular · 89d