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"
2761–2784 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
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