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

5,282 results for "health"
2809–2832 of 5,282
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 10, 2006
CT PERFUSION 4
K052839 · JAK
Ge Healthcare
Radiology · 154d
Cleared Mar 09, 2006
LIBERTY GLUCOSE CONTROL SOLUTION
K060481 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 14d
Cleared Mar 09, 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
K060426 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 16d
Cleared Mar 09, 2006
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K053645 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 69d
Cleared Mar 08, 2006
WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
K060251 · IOR
Well Home Health Products Co.
Physical Medicine · 36d
Cleared Mar 07, 2006
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · INO
Merits Health Products Co., Ltd.
Physical Medicine · 39d
Cleared Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS...
K053512 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 62d
Cleared Feb 16, 2006
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL...
K053376 · ILY
Chung Cheng Electric Heating Co., Ltd.
Physical Medicine · 73d
Cleared Feb 15, 2006
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
K053575 · JOW
Hygia Health Services, Inc.
Cardiovascular · 55d
Cleared Feb 13, 2006
MARCH HEALTHCARE HEALTH MONITORING KIT
K060194 · DXN
March Healthcare Corporation
Cardiovascular · 19d
Cleared Feb 03, 2006
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN,...
K051217 · MHX
Ge Healthcare
Cardiovascular · 267d
Cleared Feb 01, 2006
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
K052608 · DRG
Bl Healthcare, Inc.
Cardiovascular · 132d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA...
K052975 · MSX
Ge Healthcare
Cardiovascular · 88d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING...
K051400 · MHX
Ge Healthcare
Cardiovascular · 234d
Cleared Jan 17, 2006
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER
K051566 · FLL
Proton Healthcare , Ltd.
General Hospital · 217d
Cleared Jan 13, 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976 · DQK
Ge Healthcare
Cardiovascular · 81d
Cleared Jan 12, 2006
ALARIS SAFETY MALE LUER
K053049 · FPA
Cardinal Health, Alaris Products
General Hospital · 76d
Cleared Jan 05, 2006
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · KGO
Cardinalhealth
General Hospital · 43d
Cleared Dec 30, 2005
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · MMI
Bayer Healthcare, LLC
Chemistry · 65d
Cleared Dec 29, 2005
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
K052972 · MSX
Ge Healthcare
Cardiovascular · 66d
Cleared Dec 27, 2005
A-200 POWERED WHEELCHAIR
K052706 · ITI
Otto Bock Healthcare LP
Physical Medicine · 90d
Cleared Dec 23, 2005
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
K052790 · LHI
Cardinal Health, Alaris Products
General Hospital · 81d
Cleared Dec 22, 2005
MEDILOG DARWIN HOLTER ANALYSIS
K053369 · DQK
Huntleigh Healthcare
Cardiovascular · 17d
Cleared Dec 14, 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · MMI
Bayer Healthcare, LLC
Chemistry · 92d