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

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176,076 results
162817–162840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1981
S/P SURE-CAP C
K812922 · GIO
American Dade
Hematology · 18d
Cleared Nov 06, 1981
S/P SURE-CAP N
K812923 · GIO
American Dade
Hematology · 18d
Cleared Nov 06, 1981
ALT-QUANTICHROM
K812926 · CKA
Abbott Laboratories
Chemistry · 18d
Cleared Nov 06, 1981
ARTERIOGRAM TRAY
K812927 · FMG
American Pharmaseal Div. Ahsc
Radiology · 18d
Cleared Nov 06, 1981
LANCER SPECIMEN CONTAINER
K812933 · FMH
Sherwood Medical Co.
General Hospital · 17d
Cleared Nov 06, 1981
MONOJECT PREFILLED SYRINGES
K812934 · FMF
Sherwood Medical Co.
General Hospital · 17d
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