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"
2953–2976 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 02, 2004
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
K041693 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 163d
Cleared Nov 30, 2004
PUMP CONNECTIVITY INTERFACE
K040985 · FRN
Baxter Healthcare Corp
General Hospital · 229d
Cleared Nov 26, 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936 · FPA
Baxter Healthcare Corp
General Hospital · 32d
Cleared Nov 18, 2004
IOP8 INTRA OPERATIVE PROBE
K032315 · ITX
Huntleigh Healthcare, Inc.
Radiology · 479d
Cleared Nov 17, 2004
TIDI BRAND STERILIZATION WRAP
K042580 · FRG
Banta Healthcare Group, Ltd.
General Hospital · 56d
Cleared Nov 10, 2004
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
K043018 · DXN
Omron Healthcare, Inc.
Cardiovascular · 8d
Cleared Nov 10, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF,...
K042853 · DXN
Health & Life Co., Ltd.
Cardiovascular · 26d
Cleared Nov 02, 2004
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
K042866 · IZL
Ge Healthcare Technologies
Radiology · 15d
Cleared Oct 26, 2004
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J &...
K042802 · DXN
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
BAXJECT II
K042410 · LHI
Baxter Healthcare Corp
General Hospital · 31d
Cleared Oct 08, 2004
ACU-STRAP MOTION SICKNESS BAND
K041877 · MVV
Health Ent., Inc.
Neurology · 88d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL C-1000
K041211 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-600
K041210 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-500
K041208 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d
Cleared Sep 30, 2004
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS...
K042267 · MSH
Inovel, LLC
General Hospital · 38d
Cleared Sep 30, 2004
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 44d
Cleared Sep 29, 2004
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
K042015 · CGA
Bayer Healthcare, Diagnostics Division
Chemistry · 64d
Cleared Sep 24, 2004
MODIFIED SPACEMAKER SYSTEM
K042412 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 17d
Cleared Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251 · GKZ
Bayer Healthcare, LLC
Hematology · 28d
Cleared Sep 13, 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER...
K041694 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 13, 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 10, 2004
HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A,...
K041867 · NLF
Hygia Health Services, Inc.
Anesthesiology · 63d
Cleared Sep 09, 2004
CRANIAL HELMET
K041215 · MVA
Otto Bock Healthcare LP
Neurology · 122d