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
166033–166056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1980
MAJOR DRESSING TRAY-MILFORD HOSP.
K802388 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 41d
Cleared Nov 12, 1980
AO NON-CONTACT II TONOMETER
K802419 · HKX
American Optical Corp.
Ophthalmic · 37d
Cleared Nov 12, 1980
PHADEBACT HAEMOPHILUS TEST
K802423 · GRO
Pharmacia, Inc.
Microbiology · 40d
Cleared Nov 12, 1980
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
K802431 · ETB
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 37d
Cleared Nov 12, 1980
GESTE FOLLOW KIT DETERM. OF HPL
K802454 · JMF
Syn-Kit, Inc.
Immunology · 35d
Cleared Nov 12, 1980
BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
K802465 · FKR
Renal Systems, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 12, 1980
DISSCAP HOLLOW FIBER DIALYZER
K802466 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 35d
Cleared Nov 12, 1980
T4 RADIOIMMUNOASSAY KIT
K802469 · CDX
American Diagnostic Corp.
Chemistry · 34d
Cleared Nov 12, 1980
T3 RADIOIMMUNOASSAY KIT
K802470 · CDP
American Diagnostic Corp.
Chemistry · 34d
Cleared Nov 12, 1980
CHEMTROLER
K802471 · JQP
Fletcher Flora Computer Products, Inc.
Chemistry · 34d
Cleared Nov 12, 1980
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
K802473 · DQX
Medrad, Inc.
Cardiovascular · 3d
Cleared Nov 12, 1980
LIGMAJECT
K802483 · EJI
Alan J. Khedarri D.D.S., Inc.
Dental · 34d
Cleared Nov 12, 1980
REIGNING CROWN BRIDGE
K802489 · EBG
Oki Shiks USA , Ltd.
Dental · 33d
Cleared Nov 12, 1980
REIGNING REPAIR EPOXY RESIN
K802491 · EBI
Oki Shiks USA , Ltd.
Dental · 33d
Cleared Nov 12, 1980
REIGNING ARTIFICIAL TEETH
K802492 · ELM
Oki Shiks USA , Ltd.
Dental · 33d
Cleared Nov 12, 1980
SPUTASOL
K802493 · IBG
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
GAS GENERATING KIT SYSTEM FOR CAMPYLOB.
K802494 · KZJ
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
OPTOCHIN DIAGNOSTIC DISC
K802496 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
BACTIRACIN DIAGNOSTIC DISC
K802497 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
MUELLER HINTON AGAR
K802498 · JTZ
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
X-FACTOR DISCS
K802500 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
V FACTOR DISCS
K802501 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
X & V FACTOR DISCS
K802502 · JTO
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Nov 12, 1980
SPONGE SURGICAL GUAZE RADIOPAQUE
K802504 · EFQ
Barnhardt Mfg. Co.
General & Plastic Surgery · 28d