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
156097–156120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 26, 1983
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
K831271 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 98d
Cleared Jul 26, 1983
SOLARCRYL CUSTOM TRAY MATERIAL
K831293 · EBH
Solar Dental Co., Inc.
Dental · 97d
Cleared Jul 26, 1983
POLYCHACO FIA-ABS TEST FOR SYPHILIS
K831296 · JWL
Parasitic Disease Consultants
Immunology · 97d
Cleared Jul 26, 1983
COAXIAL BALLOON URETHRAL DILATOR
K831384 · FAH
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 89d
Cleared Jul 26, 1983
AVL 0073 MICROSAMPLER
K831395 · FMI
Avl Scientific Corp.
General Hospital · 88d
Cleared Jul 26, 1983
ULTRA PULSATOR
K831472
Medelco , Ltd.
Physical Medicine · 81d