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
162625–162648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1981
HEMASITE VASCULAR ACCESS SHUNT HM-1000
K813237 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · DTB
Pacesetter Systems
Cardiovascular · 310d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · DTB
Pacesetter Systems
Cardiovascular · 298d
Cleared Nov 27, 1981
SNIFF AIR COMPRESSOR #SF-6
K812767 · BTI
Timeter Instrument Corp.
Anesthesiology · 53d
Cleared Nov 27, 1981
EIA RUBELLA
K812787 · LFX
Gilford
Microbiology · 53d
Cleared Nov 27, 1981
PFT SCREENER (SYSTEM 1100)
K812792 · BTY
Medical Graphics Corp.
Anesthesiology · 52d
Cleared Nov 27, 1981
TOTAL PROTEIN REAGENT SET
K812833 · CEK
Anco Medical Reagents & Assoc.
Chemistry · 49d
Cleared Nov 27, 1981
TOTAL & DIRECT BILIRUBIN REAGENT SET
K812841 · CIG
Anco Medical Reagents & Assoc.
Chemistry · 49d
Cleared Nov 27, 1981
RADCLIFFE VENTILATOR MARK 5
K812953 · CBK
Cairco , Ltd.
Anesthesiology · 37d
Cleared Nov 27, 1981
GEL ELECTRODE
K813013 · DRX
Arndt Automation & Assoc.
Cardiovascular · 31d
Cleared Nov 27, 1981
POLYSTAN HEART LUNG MACHINE SYS
K813034 · DTQ
Advocacy International, Ltd.
Cardiovascular · 30d
Cleared Nov 27, 1981
POLYSTAN VERTICLUDE BLOOD PUMP
K813035 · DWB
Advocacy International, Ltd.
Cardiovascular · 30d
Cleared Nov 27, 1981
BIO-STIMULATOR, MODEL 400
K813100 · GZJ
Med-Western Electronics, Inc.
Neurology · 24d
Cleared Nov 27, 1981
CARDIOBEEPER MEMORY MONITOR
K813101 · DXY
Survival Technology, Inc.
Cardiovascular · 24d
Cleared Nov 27, 1981
EPC FILTER
K813123 · DRR
Codman & Shurtleff, Inc.
Cardiovascular · 23d
Cleared Nov 27, 1981
INTERFACE ARTERIAL BLOOD FILTER
K813131 · DTM
Medical, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
VYGON EXTENSION TUBES & CONNECTORS
K813140 · DQO
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
VYGON STOPCOCKS & RAMPS(MANIFOLDS)
K813141 · DTL
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
LEADER-CATH
K813142 · DQO
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
DESILET
K813143 · DYB
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
INTRAFLON, INTRAFLUX, INTRAVALVE
K813144 · DQR
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
SYVA ADVANCE TM FLUOROMETER
K813146 · KHO
Syva Co.
Chemistry · 21d
Cleared Nov 27, 1981
20CC GLASS CONTROL SYRINGE
K813175 · FMF
Abco Dealers, Inc.
General Hospital · 18d
Cleared Nov 27, 1981
HDL-C EIKEN
K813192 · LBS
Syn-Kit, Inc.
Chemistry · 10d