FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
1993–2016 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 16, 2012
VIGNET TELEHEALTH MANAGER
K113446 · DRG
Vignet, Inc.
Cardiovascular · 238d
Cleared Jul 13, 2012
CAPNOGRAPHY PAD (92516)
K121017 · CCK
Spacelabs Healthcare
Anesthesiology · 100d
Cleared Jul 13, 2012
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
K113192 · NBW
Infopia Co, Ltd.
Chemistry · 256d
Cleared Jul 13, 2012
MONICA AN24
K112390 · OSP
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 330d
Cleared Jul 12, 2012
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
K121529 · LZA
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Jul 12, 2012
CS1000 LIGHT THERAPY DEVICE
K110558 · ILY
Genesis Health Light Corporation
Physical Medicine · 500d
Cleared Jul 05, 2012
BLUE POWER FREE NITRILE EXAMINATION GLOVE
K121464 · LZA
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Jul 03, 2012
UTB BLUE POWDER FREE NITRILE
K121506 · LZA
Northstar Healthcare Holdings
General Hospital · 43d
Cleared Jul 03, 2012
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
K120941 · DRG
Constant Care, LLC
Cardiovascular · 96d
Cleared Jun 29, 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM...
K121634 · FPA
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Jun 29, 2012
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092 · FPA
Baxter Healthcare Corp
General Hospital · 80d
Cleared Jun 29, 2012
INTELLISPACE ECG
K120855 · DQK
Philips Health Care
Cardiovascular · 100d
Cleared Jun 28, 2012
WI-FI BODY SCALE
K121527 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 36d
Cleared Jun 28, 2012
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
K121087 · NBW
Bayer Healthcare
Chemistry · 79d
Cleared Jun 15, 2012
READY VIEW
K113456 · LLZ
Ge Healthcare (Ge Medical Systems Scs)
Radiology · 207d
Cleared Jun 14, 2012
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
K121470 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Jun 13, 2012
DURABLUE STERILIZATION WRAP
K120658 · FRG
Cardinal Health200, LLC
General Hospital · 100d
Cleared Jun 11, 2012
BLEASE700/900 SERIES VENTILATORS
K112729 · CBK
Spacelabs Healthcare
Anesthesiology · 265d
Cleared Jun 06, 2012
ARIATELE TELEMETRY TRANSMITTER (96281)
K121480 · MHX
Spacelabs Healthcare
Cardiovascular · 19d
Cleared Jun 05, 2012
CENTRICITY PACS-IW
K121387 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 28d
Cleared Jun 01, 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · DXN
Andon Health Co, Ltd.
Cardiovascular · 88d
Cleared Jun 01, 2012
CARDINAL HEALTH DURABLUE STERILIZATION WRAP
K120542 · FRG
Cardinal Health-Medical Products and...
General Hospital · 99d
Cleared May 30, 2012
3M SPOTON TEMPERATURE MONITORING SYSTEM
K120412 · FLL
Arizant Healthcare, Inc.
General Hospital · 110d
Cleared May 30, 2012
SOLOHEALTH STATION
K113402 · DXN
Solohealth, Inc.
Cardiovascular · 195d