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
167209–167232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1980
RADIOMETER ACID BASE LABORATORY-ABL-3
K800224 · CHL
The London Co.
Chemistry · 17d
Cleared Feb 22, 1980
ABCO MERCURIAL SPHYGMOMANOMETER
K800236 · DXQ
Abco Dealers, Inc.
Cardiovascular · 17d
Cleared Feb 22, 1980
FOLDING CRUTCH
K800237 · IPR
Husa Folding Crutch Co., Inc.
Physical Medicine · 17d
Cleared Feb 22, 1980
450 DRILL/800 DRILL
K800311 · KIJ
Black & Decker(Tm)
Orthopedic · 10d
Cleared Feb 22, 1980
150 DRIVER/REAMER
K800312 · KIJ
Black & Decker(Tm)
Orthopedic · 10d
Cleared Feb 22, 1980
SAGITTAL SAW
K800313 · KIJ
Black & Decker(Tm)
Orthopedic · 10d
Cleared Feb 22, 1980
VOLU-SOL ORANGE G-6 STAIN
K800323 · HZH
Volu Sol Medical Industries
Pathology · 10d
Cleared Feb 22, 1980
VOLU-SOL HARRIS HEMATOXYLIN
K800324 · HYK
Volu Sol Medical Industries
Pathology · 10d
Cleared Feb 21, 1980
DENTALEEN
K791160 · EMA
Denpac Corp.
Dental · 244d
Cleared Feb 21, 1980
RESPIRATION/APNEA AMPLIFIER MODEL 3105
K792528 · BZQ
Electronics For Medicine, Inc.
Anesthesiology · 76d
Cleared Feb 21, 1980
INTRACULA II
K800099 · IYO
Kt Medical, Inc.
Radiology · 38d
Cleared Feb 21, 1980
7200 MA ECHO-OPHTHALMOSCOPE
K800100 · IYO
Kt Medical, Inc.
Radiology · 38d
Cleared Feb 21, 1980
DISPOSAL LITER BREATHING BAG
K800155 · BTC
Dryden Corp.
Anesthesiology · 29d
Cleared Feb 21, 1980
NASOSTAT
K800175 · EMX
Edward Weck, Inc.
Ear, Nose, Throat · 24d
Cleared Feb 21, 1980
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
K800178 · DWE
Extracorporeal Medical Specialities,...
Cardiovascular · 24d
Cleared Feb 21, 1980
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
K800199 · CHH
Simmler, Inc.
Chemistry · 22d
Cleared Feb 21, 1980
LINEAR ENZYMATIC GLUCOSE SYSTEM
K800200 · CGA
Simmler, Inc.
Chemistry · 22d
Cleared Feb 21, 1980
SKIL-CARE LEG PADS
K800208 · KNO
Skil-Care Corp.
Physical Medicine · 20d
Cleared Feb 21, 1980
IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
K800228 · DBE
Clinical Sciences, Inc.
Immunology · 16d
Cleared Feb 21, 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · DBM
Clinical Sciences, Inc.
Immunology · 16d
Cleared Feb 21, 1980
ABCO ULTRA SLIDE MICROSCOPE SLIDE
K800232 · KEW
Abco Dealers, Inc.
Pathology · 16d
Cleared Feb 21, 1980
RH-HR NEGATIVE CONTROL REAGENT
K800239 · KSF
Gotham Biologics, Inc.
Hematology · 16d
Cleared Feb 21, 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 15d
Cleared Feb 19, 1980
VISALENS ALL PURPOSE SOLUTION FOR LENS
K791523 · HPX
Pfizer, Inc.
Ophthalmic · 193d