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
147769–147792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1985
QRI-FLOW URINE FLOW MEASURING DEVICE
K851266 · KNX
Bio-Flow, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 27, 1985
INTERFACE TRANSFUSION BLOOD FILTER #35
K851370 · CAK
Medical, Inc.
General Hospital · 83d
Cleared Jun 27, 1985
TACTICON 1600
K851441 · LRA
Medecon
Ear, Nose, Throat · 78d
Cleared Jun 27, 1985
SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
K851506 · JKA
Ncs Diagnostics, Inc.
Microbiology · 73d
Cleared Jun 27, 1985
RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
K851628 · DXJ
Eaton Medical Group
Cardiovascular · 70d
Cleared Jun 27, 1985
OSTOMY BAGS URETHEROSTOMY
K851678 · EXB
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 27, 1985
OSTOMY BAGS COLOSTOMY
K851679 · EXB
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 27, 1985
OSTOMY BAGS ILEOSTOMY
K851680 · EXB
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 27, 1985
ASCON SURGICAL INSTRUMENTS
K852057 · HNR
Ascon Medical Instruments, Ltd.
Ophthalmic · 49d
Cleared Jun 27, 1985
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087 · FLL
Terumo Medical Corp.
General Hospital · 45d
Cleared Jun 27, 1985
KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS
K852243 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 35d
Cleared Jun 27, 1985
STILLE BONE CUTTING RORCEPS 10 1/4 IN SS 420 & 416
K852245
The Huxley Instrument Corp.
General & Plastic Surgery · 35d
Cleared Jun 27, 1985
870 SURGICAL SYS CONTROL PULSE MODIFICATION
K852252 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 33d
Cleared Jun 27, 1985
SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER
K852258
Kleen Test Products
General & Plastic Surgery · 34d
Cleared Jun 27, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · DHB
Pharmacia, Inc.
Immunology · 34d
Cleared Jun 27, 1985
CATAPRESS TOURNIGUET
K852277 · GAX
Boehringer Ingelheim Pharmaceuticals,...
General & Plastic Surgery · 29d
Cleared Jun 27, 1985
RETRACTOR, SURGICAL
K852330 · GAD
Scholten Surgical Instruments, Inc.
General & Plastic Surgery · 27d
Cleared Jun 27, 1985
PHILIPS SOLARIUM HP 3134
K852348 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 27d
Cleared Jun 27, 1985
MANAN TROCAR STYLE BIOPSY NEEDLE
K852426 · GAA
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Jun 27, 1985
MANAN SPINAL NEEDLE
K852427 · GAA
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Jun 27, 1985
MANAN EPIDURAL NEEDLE
K852428 · GCB
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Jun 27, 1985
INFUSAFE 205 CATOLOG NO. 205.000
K852433 · FLN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 17d
Cleared Jun 27, 1985
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · FPA
Y
General Hospital · 20d
Cleared Jun 26, 1985
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · DXN
Medtronic Vascular
Cardiovascular · 236d