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"

2881–2904 of 5,198

Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital

Cleared Jan 10, 2005

HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR

Home Health Technology Co., Ltd.

Physical Medicine · 33d

Cleared Dec 22, 2004

ASCENSIA ELITE DIABETES CARE SYSTEM

Bayer Healthcare, LLC

Chemistry · 21d

Cleared Dec 22, 2004

HEALTHSTAR ELITE

Hill Laboratories Co.

Physical Medicine · 29d

Cleared Dec 22, 2004

ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM

Bayer Healthcare, LLC

Chemistry · 37d

Cleared Dec 17, 2004

NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY

Nichols Institute Diagnostics

Chemistry · 79d

Cleared Dec 13, 2004

WHEELCHAIR, MODEL 8500-II

Cycling and Health Tech. Industry R&D...

Physical Medicine · 11d

Cleared Dec 09, 2004

Armstrong Healthcare Limited

Neurology · 189d

Cleared Dec 08, 2004

ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN,...

General Hospital · 77d

Cleared Dec 06, 2004

H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM

Health & Life Co., Ltd.

Cardiovascular · 19d

Cleared Dec 06, 2004

MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY...

Ansell Healthcare Products, Inc.

General Hospital · 55d

Cleared Dec 02, 2004

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES

Hangzhou Hua'An Medical & Health...

Cardiovascular · 163d

Cleared Nov 30, 2004

PUMP CONNECTIVITY INTERFACE

Baxter Healthcare Corp

General Hospital · 229d

Cleared Nov 26, 2004

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE

Baxter Healthcare Corp

General Hospital · 32d

Cleared Nov 18, 2004

IOP8 INTRA OPERATIVE PROBE

Huntleigh Healthcare, Inc.

Radiology · 479d

Cleared Nov 17, 2004

TIDI BRAND STERILIZATION WRAP

Banta Healthcare Group, Ltd.

General Hospital · 56d

Cleared Nov 10, 2004

OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906

Omron Healthcare, Inc.

Cardiovascular · 8d

Cleared Nov 10, 2004

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF,...

Health & Life Co., Ltd.

Cardiovascular · 26d

Cleared Nov 02, 2004

AMX5 AND AMX5D MOBILE X-RAY SYSTEMS

Ge Healthcare Technologies

Radiology · 15d

Cleared Oct 26, 2004

H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J &...

Health & Life Co., Ltd.

Cardiovascular · 18d

Not Cleared Oct 12, 2004

VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

DEN040007 · NRV

Digital Angel Corporation

General Hospital · 69d

Cleared Oct 08, 2004

Baxter Healthcare Corp

General Hospital · 31d

Cleared Oct 08, 2004

ACU-STRAP MOTION SICKNESS BAND

Health Ent., Inc.

Neurology · 88d

Cleared Oct 01, 2004

POWERED WHEELCHAIR, MODEL C-1000

Otto Bock Healthcare LP

Physical Medicine · 144d

Cleared Oct 01, 2004

POWERED WHEELCHAIR, MODEL B-600

Otto Bock Healthcare LP

Physical Medicine · 144d