Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
168049–168072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1980
LDC CHROMATOGRAPHY ACCESSORY MODULE B
K800046 · KIE
Laboratory Data Control
Toxicology · 47d
Cleared Feb 22, 1980
VXTRA BACK PACK EKG ELECTRODE CAT. NO.
K792436 · DRX
Vxtra Corp.
Cardiovascular · 86d
Cleared Feb 22, 1980
UCA LOTION
K792490
Vanaray Laboratories, Inc.
Neurology · 81d
Cleared Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · DBL
Kallestad Laboratories, Inc.
Immunology · 66d
Cleared Feb 22, 1980
SMITH SUBTALAR PEG
K792670 · LXH
Dow Corning Wright
Orthopedic · 57d
Cleared Feb 22, 1980
BOOTS - OUTDOOR CARRIER FOR THE AMIGO
K800209 · ITI
Amigo Sales, Inc.
Physical Medicine · 21d
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