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
161977–162000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1981
BEHIND-THE-EAR MODEL 115
K812937 · ESD
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
IN-THE-EAR MODEL 821
K812938 · ESD
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
IN-THE-EAR MODEL 101M
K812939 · ESD
Danavox, Inc.
Ear, Nose, Throat · 17d
Cleared Nov 06, 1981
SLICK ENDOTRACHEAL TUBE
K812943 · BTR
Polamedco, Inc.
Anesthesiology · 17d
Cleared Nov 06, 1981
LIQUILYME BUN REAGENT
K812945 · LFP
Amresco, Inc.
Chemistry · 17d
Cleared Nov 06, 1981
TRONZO HIP
K812946 · DXQ
Biomet, Inc.
Cardiovascular · 17d
Cleared Nov 06, 1981
RION AUDIOMETER AA-67
K812951 · GWO
Rion Acoustic Instruments, Inc.
Neurology · 16d
Cleared Nov 06, 1981
RION AUDIOMETER AA-68
K812952 · GWO
Rion Acoustic Instruments, Inc.
Neurology · 16d
Cleared Nov 06, 1981
ACCURATE BETA
K812967 · JHJ
Organon, Inc.
Chemistry · 15d
Cleared Nov 06, 1981
FIAX RHEUMATOID FACTOR TEST KIT
K812968 · DHR
Intl. Diagnostic Technology
Microbiology · 15d
Cleared Nov 06, 1981
S/P CAPILLARY TUBES, HEPARINIZED (2A)
K812969 · GIO
American Dade
Hematology · 15d
Cleared Nov 06, 1981
S/P CAPILLARY TUBES, HEPARINIZED (3A)
K812970 · GIO
American Dade
Hematology · 15d
Cleared Nov 06, 1981
RA LATEX TEST
K812972 · DHR
Oxoid U.S.A., Inc.
Microbiology · 14d
Cleared Nov 06, 1981
URIC ACID SYSTEM PACK TEST
K812978 · KNK
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Nov 06, 1981
MA-2 VENTILATOR
K812980 · CBK
Bio-Medical Repair, Inc.
Anesthesiology · 14d
Cleared Nov 06, 1981
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)
K812981 · FPK
Venusa , Ltd.
General Hospital · 14d
Cleared Nov 06, 1981
FIBRI-FILTER 20
K813001 · FPB
Tri-Med, Inc.
General Hospital · 11d
Cleared Nov 06, 1981
P.P.P. TREATMENT CABINET
K813003 · ERA
Precision Professional Products
Ear, Nose, Throat · 11d
Cleared Nov 06, 1981
STERILE BASIN SETS
K813012 · LDQ
Medspec Corp.
General & Plastic Surgery · 10d
Cleared Nov 06, 1981
OXYTRON OXYGEN GENERATOR
K813018 · CAW
Elmore Technology Corp.
Anesthesiology · 10d
Cleared Nov 05, 1981
HERPES
K811021 · GQN
Immuno-Diagnostic Products, Inc.
Microbiology · 204d
Cleared Nov 05, 1981
AUTOMATED ELECTROCAUTERY SYSTEM
K812213 · KNS
University of Washington
Gastroenterology & Urology · 92d
Cleared Nov 05, 1981
ENGSTROM ERICA
K812642 · CBK
Lkb Instruments, Inc.
Anesthesiology · 50d
Cleared Nov 05, 1981
URICAR
K812700 · KNK
Hi Chem, Inc.
Chemistry · 43d