FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,280 results for "health"
2041–2064 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 27, 2012
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
K121897 · KGO
Cardinal Health, Inc.
General Hospital · 28d
Cleared Jul 27, 2012
ZEOBI
K121338 · ILX
Ivivi Health Science, LLC
Physical Medicine · 85d
Cleared Jul 26, 2012
CONTOUR NEXT BLOOD GLUCOSE METER
K121190 · LFR
Bayer Healthcare, LLC
Chemistry · 98d
Cleared Jul 26, 2012
WI-FI BODY SCALE
K120896 · MNW
Andon Health Co, Ltd.
Gastroenterology & Urology · 122d
Cleared Jul 23, 2012
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE...
K121907 · CJO
Siemens Healthcare Diagnostics
Chemistry · 24d
Cleared Jul 20, 2012
CR 10-X DIGITIZER
K121948 · MQB
Agfa Healthcare N.V.
Radiology · 17d
Cleared Jul 18, 2012
ST80I STRESS TEST SYSTEM
K121638 · DQK
Philips Health Care
Cardiovascular · 44d
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