Search FDA 510(k) Database

Cleared Apr 15, 2019

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

K182828 · NLM

Surgical Instrument Service and...

General & Plastic Surgery · 192d

Cleared Apr 15, 2019

Diode Laser Treatment System

K182924 · GEX

Weifang KM Electronics Co., Ltd.

General & Plastic Surgery · 178d

Cleared Apr 15, 2019

SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16

K183548 · JAK

Siemens Medical Solutions USA, Inc.

Radiology · 116d

Cleared Apr 15, 2019

BriefCase

K190072 · QAS

Aidoc Medical , Ltd.

Radiology · 90d

Cleared Apr 15, 2019

PreXion3D Explorer

K190320 · OAS

Prexion Corporation

Radiology · 61d

Cleared Apr 15, 2019

NDOHD High Definition Imaging System (NDOHD)

K190420 · LLZ

Altaravision, Inc.

General & Plastic Surgery · 53d

Cleared Apr 15, 2019

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test...

K190705 · LCX

Wholepower Biotech Co., Ltd.

Chemistry · 27d

Cleared Apr 13, 2019

INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy...

K190690 · DTZ

Sorin Group Italia S.R.L.

Cardiovascular · 26d

Cleared Apr 12, 2019

D-Clip

K180757 · HCH

Peter Lazic GmbH

Neurology · 386d

Cleared Apr 12, 2019

Ascent Cardiorespiratory Diagnostic Software

K181912 · BTY

Medical Graphics Corporation

Anesthesiology · 269d

Cleared Apr 12, 2019

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

K181915 · LCP

Ixensor Co, Ltd.

Chemistry · 269d

Cleared Apr 12, 2019

KardiaMobile, KardiaStation

K182396 · DXH

AliveCor, Inc.

Cardiovascular · 220d

Cleared Apr 12, 2019

InstaRISPACS / InstaZFP / InstaMobi v5.0

K182572 · LLZ

Meddiff Technologies Pvt. , Ltd.

Radiology · 206d

Cleared Apr 12, 2019

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

K182619 · PEN

Genmark Diagnostics, Incorporated

Microbiology · 200d

Cleared Apr 12, 2019

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet...

K182640 · LZA

Shandong Hengya Packaging Printing...

General Hospital · 200d

Cleared Apr 12, 2019

3T 32 Channel Head Coil

K182737 · MOS

Nova Medical, Inc.

Radiology · 196d

Cleared Apr 12, 2019

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner...

K182891 · PSW

Cs Medical, LLC

General Hospital · 179d

Cleared Apr 12, 2019

PuraSinus

K183015 · NHB

3-D Matrix, Inc.

Ear, Nose, Throat · 163d

Cleared Apr 12, 2019

Deep Learning Image Reconstruction

K183202 · JAK

Ge Medical Systems, LLC

Radiology · 144d

Cleared Apr 12, 2019

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...

K183490 · DTZ

Medtronic, Inc.

Cardiovascular · 116d

Cleared Apr 12, 2019

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

K183599 · OGZ

Infraredx, Inc.

Cardiovascular · 107d

Cleared Apr 12, 2019

ArgenZ HT+

K190079 · EIH

The Argen Corporation

Dental · 86d

Cleared Apr 12, 2019

Baby Gorilla/Gorilla Plating System

K190365 · HRS

Paragon 28, Inc.

Orthopedic · 56d

Cleared Apr 12, 2019

SyncVision System

K190626 · OWB

Volcano Corporation

Radiology · 32d