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

5,281 results for "health"
2929–2952 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 18, 2005
SECURELOC
K050023 · DYB
Specialized Health Products, Inc.
Cardiovascular · 44d
Cleared Feb 16, 2005
TURBO TEMP TRIO
K050230 · FLL
Cardinal Health, Alaris Products
General Hospital · 15d
Cleared Feb 09, 2005
HL 188 & HL 189 BODY FAT METER
K043414 · MNW
Health & Life Co., Ltd.
Gastroenterology & Urology · 58d
Cleared Feb 08, 2005
ADVIA IMS CARBAMAZEPINE METHOD
K042808 · KLT
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 08, 2005
ADVIA IMS VALPROIC ACID METHOD
K042807 · LEG
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 03, 2005
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200
K042719 · ITI
Home Health Technology Co., Ltd.
Physical Medicine · 126d
Cleared Jan 26, 2005
BEWELL, MODEL SC 20
K043326 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 55d
Cleared Jan 19, 2005
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES...
K043508 · KGO
Ansell Healthcare Products, LLC
General Hospital · 30d
Cleared Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 75d
Cleared Jan 18, 2005
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K042709 · EZL
Tyco Healthcare
Gastroenterology & Urology · 110d
Cleared Jan 12, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · LNH
Ge Healthcare
Radiology · 49d
Cleared Jan 12, 2005
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 380d
Cleared Jan 10, 2005
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR
K043376 · ITI
Home Health Technology Co., Ltd.
Physical Medicine · 33d
Cleared Dec 22, 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · NBW
Bayer Healthcare, LLC
Chemistry · 21d
Cleared Dec 22, 2004
HEALTHSTAR ELITE
K043239 · ITH
Hill Laboratories Co.
Physical Medicine · 29d
Cleared Dec 22, 2004
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · NBW
Bayer Healthcare, LLC
Chemistry · 37d
Cleared Dec 17, 2004
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
K042676 · DHA
Nichols Institute Diagnostics
Chemistry · 79d
Cleared Dec 13, 2004
WHEELCHAIR, MODEL 8500-II
K043332 · IOR
Cycling and Health Tech. Industry R&D...
Physical Medicine · 11d
Cleared Dec 10, 2004
PALMSCAN AP2000
K043287 · IYO
Micromedical Devices, Inc.
Radiology · 11d
Cleared Dec 09, 2004
PATHFINDER
K041477 · HAW
Armstrong Healthcare Limited
Neurology · 189d
Cleared Dec 08, 2004
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN,...
K042574 · KGO
Cardinalhealth
General Hospital · 77d
Cleared Dec 06, 2004
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
K043186 · DXN
Health & Life Co., Ltd.
Cardiovascular · 19d
Cleared Dec 06, 2004
MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY...
K042817 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 55d