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
156937–156960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1983
SAVE-A-BAKE PORCELAIN POLISH
K831483 · EIH
Denpac Corp.
Dental · 80d
Cleared Jul 28, 1983
COMPOSI-GLAZE
K831484 · EBF
Denpac Corp.
Dental · 80d
Cleared Jul 28, 1983
KENNEDY TIBIAL COMPONENT
K831513 · HSX
Biomet, Inc.
Orthopedic · 77d
Cleared Jul 28, 1983
SODIUM HYPOCHLORITE 7%
K831619 · PPM
Omega Medical Diagnostics
Hematology · 70d
Cleared Jul 28, 1983
SODIUM HYPOCHLORITE 3%
K831620 · PPM
Omega Medical Diagnostics
Hematology · 70d
Cleared Jul 28, 1983
DIA STRIPS SYSTEM
K831623 · CDM
California Immuno Diagnostic, Inc.
Chemistry · 69d
Cleared Jul 28, 1983
LYOPHILIZED MICROORGANISMS
K831653 · JTR
Austin Biological Laboratories
Microbiology · 66d
Cleared Jul 28, 1983
MODIFIED SOYBEAN CASEIN DIGEST BROTH
K831671 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 66d
Cleared Jul 28, 1983
TRICYCLIC ANTIDEPRESSANTS
K831736 · DIF
Utak Laboratories, Inc.
Toxicology · 58d
Cleared Jul 28, 1983
REVOLUTION RADIAL IMMUNODIFFUSION PLATE
K831811 · JZQ
Calbiochem-Behring Corp.
Immunology · 52d
Cleared Jul 28, 1983
CO-OXIMETER CONTROL
K831813 · KHG
United Diagnostics, Inc.
Hematology · 52d
Cleared Jul 28, 1983
CALIBRATION STANDARD-HEMOGLOBIN
K831814 · KRZ
United Diagnostics, Inc.
Hematology · 52d
Cleared Jul 28, 1983
HATCH KIT
K831855 · CKG
Radioassay Systems Laboratories, Inc.
Chemistry · 49d
Cleared Jul 28, 1983
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC
K831866 · JJQ
Varian Assoc., Inc.
Chemistry · 48d
Cleared Jul 28, 1983
SICKLE-HEME A/S CONTROLS & A/A CONTROL
K831871 · GHM
Anco Medical Reagents & Assoc.
Chemistry · 45d
Cleared Jul 28, 1983
COMPACT FOUR
K831896 · GWF
Nicolet Biomedical Instruments
Neurology · 44d
Cleared Jul 28, 1983
MACLEAN-FOGG, DISP. BASE MOLD
K831900 · KER
Polymer Technology Corp.
Pathology · 44d
Cleared Jul 27, 1983
PORTABLE AUTOCLAVES
K830931 · FLE
Arnold & Sons
General Hospital · 126d
Cleared Jul 26, 1983
BURLINGTON STOCKINETTE
K822770
Balfour, Inc.
Physical Medicine · 315d
Cleared Jul 26, 1983
HERPELISA KIT
K822883 · LGC
M.A. Bioproducts
Microbiology · 306d
Cleared Jul 26, 1983
FR ROOT CANAL SEALER
K830764 · EKA
Shizai Corp.
Dental · 138d
Cleared Jul 26, 1983
CARDIO ARRHYTHMIA TRANSMITTER C.A.T
K830903 · DXH
Cardio Technology , Ltd.
Cardiovascular · 127d
Cleared Jul 26, 1983
LASER BRONCHOSCOPE
K831240 · EOQ
Eder Instrument Co, Inc.
Ear, Nose, Throat · 102d
Cleared Jul 26, 1983
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K831246 · CBP
Airlife, Inc.
Anesthesiology · 99d