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"
2833–2856 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 01, 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · CJM
Nichols Institute Diagnostics
Chemistry · 65d
Cleared May 26, 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · LBS
Bayer Healthcare, LLC
Chemistry · 78d
Cleared May 25, 2005
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX,...
K051092 · CCL
Ge Healthcare
Anesthesiology · 27d
Cleared May 25, 2005
CPAP HUMIDIFIER, MODEL HC238JHU
K050904 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 44d
Cleared May 19, 2005
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K051182 · MSH
Inovel, LLC
General Hospital · 10d
Cleared May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 16d
Cleared May 12, 2005
MINILOC SAFETY INFUSION SET
K050600 · FPA
Specialized Health Products, Intl.
General Hospital · 64d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518 · NDN
Cardinalhealth
Orthopedic · 142d
Cleared May 10, 2005
PIONEER U121 SERIES CPAP
K041823 · BZD
Merits Health Products Co., Ltd.
Anesthesiology · 308d
Cleared May 09, 2005
BARRIER SURGICAL GOWNS
K050786 · FYA
Molnlycke Health Care
General Hospital · 42d
Cleared May 06, 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · OLW
Ge Healthcare
Neurology · 35d
Cleared May 05, 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · MED
Healthpoint, Ltd.
General Hospital · 349d
Cleared May 02, 2005
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
K050495 · FMF
Baxter Healthcare Corp., Bioscience
General Hospital · 63d
Cleared Apr 27, 2005
SPINEMED S200B/S200C
K051013 · ITH
Cert Health Sciences, LLC
Physical Medicine · 6d
Cleared Apr 27, 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · FLL
Ge Healthcare
General Hospital · 26d
Cleared Apr 22, 2005
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K043228 · NBC
Bayer Healthcare, LLC
Chemistry · 151d
Cleared Apr 21, 2005
LANDLEX, MODEL S300X
K050792 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 24d
Cleared Apr 21, 2005
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K043531 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 121d
Cleared Apr 08, 2005
BLOOD GLUCOSE MONITORING SYSTEM
K043543 · NBW
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 08, 2005
EASYGLUCO IGM-0002 G2
K043512 · CGA
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
K050714 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
K050711 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 05, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
K050587 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Apr 05, 2005
HEALTH BUDDY APPLIANCE
K050567 · DRG
Health Hero Network, Inc.
Cardiovascular · 32d