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
161785–161808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 27, 1981
CONNECTING TUBE
K813228 · BYY
Northern Medical Industries
General Hospital · 17d
Cleared Nov 27, 1981
PATIENT UNDERPAD
K813263 · KME
The Buckeye Cellulose Corp.
General Hospital · 7d
Cleared Nov 25, 1981
FETAL PULSE DETECTORS, F50/F60
K812868 · KNG
South Carolina Medical, Inc.
Obstetrics & Gynecology · 42d
Cleared Nov 25, 1981
NECKTRAC
K813017 · HST
Lossing Orthopedic, Inc.
Neurology · 29d
Cleared Nov 24, 1981
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
K812248 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 105d
Cleared Nov 24, 1981
NEUROSPONGE PADDIE
K812390 · GDY
Winn Hirsch & Assoc.
General & Plastic Surgery · 96d