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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81313–81336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2000
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
K002053 · HAW
Orthosoft, Inc.
Neurology · 28d
Cleared Aug 03, 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 13d
Cleared Aug 03, 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
K993052 · LJS
Vygon Corp.
General Hospital · 325d
Cleared Aug 03, 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR,...
K993442 · LJS
Vygon Corp.
General Hospital · 296d
Cleared Aug 03, 2000
DETRUSAN 500
K994109 · KPI
Innovamed USA, Inc.
Gastroenterology & Urology · 241d
Cleared Aug 03, 2000
EXCELSIOR 1018 MICROCATHETER
K994155 · KRA
Boston Scientific, Target
Cardiovascular · 238d
Cleared Aug 02, 2000
LUBRIGEL PERSONAL LUBRICANT
K001077 · NUC
Sheffield Laboratories, Div. of Faria...
Obstetrics & Gynecology · 120d
Cleared Aug 02, 2000
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K001409 · CBF
Hyperbaric Technologies, Inc.
Anesthesiology · 90d
Cleared Aug 02, 2000
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
K001555 · HHK
Sims Portex , Ltd.
Obstetrics & Gynecology · 76d
Cleared Aug 02, 2000
DND 101
K001590 · KNA
Urogyn , Ltd.
Obstetrics & Gynecology · 77d
Cleared Aug 02, 2000
CHASE CARDIOVASCULAR PATCH
K001662 · DXZ
Chase Medical, Inc.
Cardiovascular · 63d
Cleared Aug 02, 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · DQX
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 02, 2000
STANDARD IMAGING HDR 1000 PLUS ION CHAMBER
K001825 · JAQ
Standard Imaging, Inc.
Radiology · 47d
Cleared Aug 02, 2000
SIGMA
K001928 · MUH
Instrumentarium Imaging, Inc.
Radiology · 37d
Cleared Aug 02, 2000
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K002009 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Aug 02, 2000
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · GXZ
Te ME NA S.A.R.L.
Neurology · 576d
Cleared Aug 02, 2000
WATER FOR TISSUE CULTURE, MODELS 1500
K993140 · MTW
Conception Technologies
Obstetrics & Gynecology · 317d
Cleared Aug 01, 2000
WIN-1 TANGO
K000204 · ITI
Duracare Medical Equipment, L.C.
Physical Medicine · 193d
Cleared Aug 01, 2000
COAXIAL DILATOR SET
K000737 · DRE
Xentek Medical, Inc.
Cardiovascular · 147d
Cleared Aug 01, 2000
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
K001182 · DXN
Microlife Corp.
Cardiovascular · 112d
Cleared Aug 01, 2000
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
K001400 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Aug 01, 2000
PHORESOR MODEL PM2000
K001410 · KTB
Iomed, Inc.
Physical Medicine · 89d
Cleared Aug 01, 2000
DA VINCHI EMG/EP ISA1004EP
K001467 · GWE
Airsep Corp.
Neurology · 83d
Cleared Aug 01, 2000
A.V. FISTULA NEEDLE
K001496 · FIE
Exelint International, Co.
Gastroenterology & Urology · 78d