FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81817–81840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2000
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR...
K992133 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 408d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · JXG
Radionics, Inc.
Neurology · 399d
Cleared Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · HWC
Stryker Endoscopy
Orthopedic · 317d
Cleared Aug 04, 2000
R.TEST EVOLUTION
K993788 · MLO
Novacor Div.
Cardiovascular · 269d
Cleared Aug 04, 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 04, 2000
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST
K994400 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Aug 03, 2000
BREAS PV 100 CPAP SYSTEM
K001553 · BZD
Vital Signs, Inc.
Anesthesiology · 77d
Cleared Aug 03, 2000
TAMPONS
K001641 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 65d
Cleared Aug 03, 2000
WATER PURIFIER
K001878 · EIA
Waterclave, LLC
Dental · 44d
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