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"
2833–2856 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 14, 2005
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
K052259 · GEH
Schering-Plough Healthcare Products,...
General & Plastic Surgery · 117d
Cleared Dec 13, 2005
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
K052866 · CBF
Oxyheal Health Group
Anesthesiology · 63d
Cleared Dec 13, 2005
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
K052522 · MNW
Stayhealthy, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · GKL
Bayer Healthcare, LLC
Hematology · 167d
Cleared Nov 30, 2005
LIBERTY GLUCOSE CONTROL, MODEL 2120031
K052980 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 37d
Cleared Nov 28, 2005
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · LYZ
Cardinalhealth
General Hospital · 70d
Cleared Nov 23, 2005
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS...
K051734 · HAW
Ge Healthcare Technologies
Neurology · 148d
Cleared Nov 22, 2005
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · DQK
Ge Healthcare
Cardiovascular · 29d
Cleared Nov 18, 2005
TRICOS T
K051722 · MQV
Baxter Healthcare Corp
Orthopedic · 144d
Cleared Nov 17, 2005
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
K051226 · BZD
Cardinalhealth
Anesthesiology · 189d
Cleared Nov 08, 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · LLZ
Ge Healthcare
Radiology · 14d
Cleared Nov 08, 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
K052877 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 27d
Cleared Nov 04, 2005
PIONEER U601 SERIES ASPIRATOR
K052650 · BTA
Merits Health Products Co., Ltd.
General & Plastic Surgery · 39d
Cleared Nov 02, 2005
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
K052880 · CCK
Ge Healthcare
Anesthesiology · 21d
Cleared Nov 01, 2005
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
K052756 · MHX
Ge Healthcare
Cardiovascular · 32d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855 · JAK
Ge Healthcare
Radiology · 17d
Cleared Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL...
K050233 · DXN
Omron Healthcare, Inc.
Cardiovascular · 269d
Cleared Oct 27, 2005
VCS, MODEL S4T
K052558 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 41d
Cleared Oct 20, 2005
ALARIS SYSTEM PC UNIT, MODEL 8001
K051641 · FRN
Cardinal Health, Alaris Products
General Hospital · 122d
Cleared Oct 14, 2005
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
K052582 · CCK
Ge Healthcare
Anesthesiology · 24d
Cleared Oct 13, 2005
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · DQA
Ge Healthcare
Anesthesiology · 13d
Cleared Oct 13, 2005
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD...
K051805 · JOW
Tyco Healthcare/Kendall
Cardiovascular · 100d
Cleared Oct 11, 2005
ADVIA IMS GLUCOSE ASSAY
K052163 · CFR
Bayer Healthcare, LLC
Chemistry · 63d
Cleared Oct 06, 2005
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
K052681 · IOR
Otto Bock Healthcare LP
Physical Medicine · 8d