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"
2785–2808 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Oct 03, 2005
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242 · JJW
Bayer Healthcare, LLC
Chemistry · 47d
Cleared Sep 20, 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · FLL
Ge Healthcare
General Hospital · 71d
Cleared Sep 16, 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · OWB
Ge Healthcare
Radiology · 14d
Cleared Sep 15, 2005
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · CAF
Allied Healthcare Products, Inc.
Anesthesiology · 123d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345 · KPQ
Ge Healthcare
Radiology · 19d
Cleared Sep 12, 2005
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W,...
K051565 · DXN
Proton Healthcare , Ltd.
Cardiovascular · 90d
Cleared Sep 09, 2005
VCS S3Y
K051130 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 129d
Cleared Sep 08, 2005
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
K052167 · CCK
Ge Healthcare
Anesthesiology · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K052154 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
K052153 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d