FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163729–163752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1981
TUBE FEEDING SET
K810573 · KNT
Harvard Laboratories
Gastroenterology & Urology · 51d
Cleared Apr 23, 1981
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · DRS
Cobe Laboratories, Inc.
Cardiovascular · 44d
Cleared Apr 23, 1981
HO-B-LITE VI UNIT
K810668 · KGL
National Biological Corp.
General & Plastic Surgery · 42d
Cleared Apr 23, 1981
THE SUNFACTORY
K810688 · FTC
Wesgold Marketing, Inc.
Radiology · 41d
Cleared Apr 23, 1981
CURITY 100% SILICONE SAFETY INDICATOR
K810690 · KOD
The Kendal Co.
Gastroenterology & Urology · 41d
Cleared Apr 23, 1981
X-RAY IMAGE INTENSIFIER PRODUCTS
K810716 · JAA
Instrumentation Camera, Inc.
Radiology · 37d
Cleared Apr 23, 1981
PROCESS CHANGE
K810721 · FPA
Medlon, Inc.
General Hospital · 37d
Cleared Apr 23, 1981
EXETER OPERATING LOUPE
K810817 · HOH
Exeter Instruments, Inc.
Ophthalmic · 30d
Cleared Apr 23, 1981
DECALCIFIER II
K810836 · KDX
Surgipath
Pathology · 28d
Cleared Apr 23, 1981
CYTOBUCKET MODEL 1024
K810848 · IFB
Cytochem, Inc.
Pathology · 27d
Cleared Apr 23, 1981
SPECTRUM ANALYZER 8000
K810851 · DXG
Radionics Medical, Inc.
Cardiovascular · 24d
Cleared Apr 23, 1981
STAR
K810873 · JWM
Intl. General Electric Co.
Radiology · 23d
Cleared Apr 23, 1981
FETAL CALF SERUM
K810874 · KIS
Tissue Culture Biologicals
Microbiology · 23d
Cleared Apr 23, 1981
OMED SILICONE INSTRUMENT COVERS
K810883 · KDC
Omega-Med Intl., Inc.
General & Plastic Surgery · 22d
Cleared Apr 23, 1981
ADEL MEDICAL BIRTHING BED, #LD-500
K810886 · HDD
Adel Medical , Ltd.
Obstetrics & Gynecology · 22d
Cleared Apr 23, 1981
BOUNDARY TUBING HOLDERS
K810888 · FZX
The Buckeye Cellulose Corp.
General & Plastic Surgery · 21d
Cleared Apr 23, 1981
COLTENE ORALLY
K810907 · EJJ
Coltene, Inc.
Dental · 20d
Cleared Apr 23, 1981
ALLOY COMPOSITE POLISH
K810912 · EJR
Moyco Industries, Inc.
Dental · 17d
Cleared Apr 23, 1981
HEMOGLOBIN ELECTROPHORESIS CONTROL
K810919 · JBD
Isolab, Inc.
Chemistry · 17d
Cleared Apr 23, 1981
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · KPO
Erika, Inc.
Gastroenterology & Urology · 17d
Cleared Apr 23, 1981
MASS SPECTROMETER-MEDSPECT II
K810938 · DOP
Allied Healthcare Products, Inc.
Toxicology · 16d
Cleared Apr 23, 1981
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · BTT
Allied Healthcare Products, Inc.
Anesthesiology · 16d
Cleared Apr 23, 1981
PENILE ERECTION MONITOR
K810944 · LIL
Medical Monitoring Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 23, 1981
REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.
K810951
Mid Tech, Inc.
Chemistry · 16d