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

5,280 results for "health"
1849–1872 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 31, 2014
LOGIQ F SERIES
K133034 · IYN
Ge Healthcare
Radiology · 127d
Cleared Jan 28, 2014
OTC PATCH
K133723 · NUH
Well-Life Healthcare Limited
Neurology · 53d
Cleared Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 157d
Cleared Jan 24, 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728 · CGX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 49d
Cleared Jan 24, 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · LCP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Jan 23, 2014
MAC 2000 ECG ANALYSIS SYSTEM
K133622 · DPS
Wipro GE Healthcare
Cardiovascular · 62d
Cleared Jan 23, 2014
KHAN KINETIC TREATMENT (KKT-M2)
K130666 · LXM
Optima Health Solutions International...
Physical Medicine · 317d
Cleared Jan 16, 2014
HEM-7311
K133379 · DXN
Omron Healthcare, Inc.
Cardiovascular · 73d
Cleared Jan 16, 2014
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
K132528 · DXG
GE Healthcare Finland Oy
Cardiovascular · 157d
Cleared Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 133d
Cleared Jan 09, 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851 · MSD
Health Line International Corporation
Gastroenterology & Urology · 288d
Cleared Jan 02, 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM...
K133512 · CDD
Siemens Healthcare Diagnostics
Chemistry · 48d
Cleared Dec 24, 2013
VENUE 50
K133431 · IYN
Ge Healthcare
Radiology · 46d
Cleared Dec 13, 2013
DURABLUE STERILIZATION WRAP
K132060 · FRG
Cardinal Health-Medical Products and...
General Hospital · 163d
Cleared Dec 13, 2013
HEPAFAT SCAN
K122035 · LNH
Resonance Health Analysis Services...
Radiology · 520d
Cleared Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · NBW
Infopia Co, Ltd.
Chemistry · 91d
Cleared Dec 12, 2013
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
K132803 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 97d
Cleared Dec 10, 2013
CANARY BREATHING SYSTEM
K131586 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 193d
Cleared Dec 09, 2013
SYNGO.PLAZA VB10A
K132532 · LLZ
Siemens AG Healthcare
Radiology · 119d
Cleared Dec 05, 2013
CAPELLA
K130788 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 258d
Cleared Dec 04, 2013
CARESCAPE MONITOR B450
K132533 · MHX
GE Healthcare Finland Oy
Cardiovascular · 114d
Cleared Dec 04, 2013
S HEALTH
K132148 · DRG
Samsung Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Dec 04, 2013
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E...
K131957 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 160d
Cleared Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · CDT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d