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
163393–163416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1981
S-610 SHUNT ADAPTOR SET
K811851 · KNR
Dravon Medical, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 31, 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
K811944 · KDI
Gambro, Inc.
Gastroenterology & Urology · 55d
Cleared Aug 31, 1981
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM
K811986 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 49d
Cleared Aug 31, 1981
BO MED BIA
K811999 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 51d
Cleared Aug 31, 1981
K-MED SILICONE SUMP DRAIN W/ SHEATH
K812025
K-Med, Inc.
General & Plastic Surgery · 42d
Cleared Aug 31, 1981
K-MED SILICONE SUMP DRAIN
K812026
K-Med, Inc.
General & Plastic Surgery · 42d
Cleared Aug 31, 1981
BORES* DEPTH GAUGE
K812069 · FTY
Santa Barbara Medco, Inc.
General & Plastic Surgery · 41d
Cleared Aug 31, 1981
RK IV SURGICAL BLADES
K812071 · GES
Santa Barbara Medco, Inc.
General & Plastic Surgery · 41d
Cleared Aug 31, 1981
POLAROID RADIOGRAPHIC FILM PROCESSOR
K812088 · IXW
Polaroid Corp.
Radiology · 40d
Cleared Aug 31, 1981
POLAROID RADIOGRAPHIC FILM CASSETTE
K812089
Polaroid Corp.
Radiology · 40d
Cleared Aug 31, 1981
ENXYMATIC CREATININE TEST
K812095 · JFY
Boehringer Mannheim Corp.
Chemistry · 38d
Cleared Aug 31, 1981
O.N.A.T.
K812102 · KNT
Latex Medical Devices, Inc.
Gastroenterology & Urology · 38d
Cleared Aug 31, 1981
KETAC-CHEM
K812115 · EMA
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
PERMAGUM
K812116 · KLE
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
PERMAGUM ADHESIVE
K812117 · KLE
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
NIMETIC POLISHING PASTE
K812118 · EJR
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
NIMETIC-DISPERS
K812119 · EBF
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
BARNES-HIND WEEKLY CLEANER
K812135 · HPX
Barnes-Hind, Inc.
Ophthalmic · 34d
Cleared Aug 31, 1981
CARDIO-DATA SYSTEM, #MARK III
K812149 · DSI
Cardio Data
Cardiovascular · 34d
Cleared Aug 31, 1981
MEDTRONIC SPECTRAX
K812153 · DXY
Medtronic Vascular
Cardiovascular · 33d
Cleared Aug 31, 1981
INTRAVASCULAR CATHETER
K812159 · FOZ
Pioneer Viggo, Inc.
General Hospital · 33d
Cleared Aug 31, 1981
MICROSURGICAL BLADE
K812160 · GES
Vxtra Corp.
General & Plastic Surgery · 33d
Cleared Aug 31, 1981
MODEL 78850 OXYGEN MONITOR
K812167 · KLK
Hewlett-Packard Co.
Anesthesiology · 32d
Cleared Aug 31, 1981
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.
K812168 · LIT
Cordis Corp.
Cardiovascular · 32d