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
167545–167568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1980
CORDIA N
K800991 · DHC
Cordis Corp.
Immunology · 14d
Cleared May 08, 1980
CORDIA NP
K800992 · DHC
Cordis Corp.
Immunology · 14d
Cleared May 08, 1980
DIGOXIN CLASP RIA KIT
K800997 · LCS
E. R. Squibb & Sons, Inc.
Toxicology · 13d
Cleared May 06, 1980
THE HOWMEDICA KINEMATIC KNEE SYSTEM
K792089 · JWH
Howmedica Corp.
Orthopedic · 202d
Cleared May 02, 1980
4200 ME ECHOENCEPHALOGRAPH
K800101 · IYO
Kt Medical, Inc.
Radiology · 109d
Cleared May 02, 1980
HOPE MODEL 126, AUTO/PROCES., DEN. FLM
K800134 · IWZ
Hope Industries, Inc.
Radiology · 102d
Cleared May 02, 1980
MEDSPEC SAFETY PINS
K800278 · KKX
Medspec Corp.
General Hospital · 87d
Cleared May 02, 1980
MEDSPEC RUBBER BANDS
K800279
Medspec Corp.
General Hospital · 87d
Cleared May 02, 1980
GAMBRO LUNDIA FIBER
K800336 · FJI
Gambro, Inc.
Gastroenterology & Urology · 77d
Cleared May 02, 1980
PULSE GENERATORS MODELS 657 & 677
K800387 · DXY
Siemens Elema AB
Cardiovascular · 70d
Cleared May 02, 1980
HELENA COLOCHECK
K800433 · KHE
Helena Laboratories
Hematology · 65d
Cleared May 02, 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · IPF
Medtronic Vascular
Physical Medicine · 59d
Cleared May 02, 1980
GENERAL ELECTRIC RADVIEW MARK I SYSTEM
K800564 · KPR
General Electric Co.
Radiology · 50d
Cleared May 02, 1980
HYFRECATOR, #733
K800617 · GEI
Birtcher Corp.
General & Plastic Surgery · 45d
Cleared May 02, 1980
MODEL 118 PULSE MEGASON
K800632 · IMI
Birtcher Corp.
Radiology · 43d
Cleared May 02, 1980
BVN
K800695 · ITG
Donald J. Mangus, M.D.
Physical Medicine · 35d
Cleared May 02, 1980
SUNHOUSE UVB ULTRAVIOLET LIGHT TANNING
K800697
Progressive Productions , Ltd.
Radiology · 35d
Cleared May 02, 1980
OHC DYNAMIC CLUB FOOT BRACE
K800715 · IQI
Ipos Luneburg
Physical Medicine · 32d
Cleared May 02, 1980
ORTHOTIC LEG GAIT CORRECTOR DEVICE
K800716 · ITO
Ipos Luneburg
Physical Medicine · 32d
Cleared May 02, 1980
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
K800745 · JSI
Remel Co.
Microbiology · 29d
Cleared May 02, 1980
SHIELD DISP. REINFORCED DRAPE SHEETS
K800817 · KKX
American Convertors Div., American...
General Hospital · 21d
Cleared May 02, 1980
HEMESPEC CHECK SET
K800852 · KRZ
Helena Laboratories
Hematology · 17d
Cleared May 02, 1980
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION
K800861 · KDQ
Snyder Laboratories, Inc.
General Hospital · 16d
Cleared May 02, 1980
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL
K800888 · DIF
Utak Laboratories, Inc.
Toxicology · 15d