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
80257–80280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2001
NEXT GENERAL M20 SURGICAL LIGHT
K003489 · FSS
Medical Illumination International, Inc.
General & Plastic Surgery · 81d
Cleared Feb 02, 2001
PORTALVISION
K003636 · IYE
Varian Medical Systems, Inc.
Radiology · 70d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · MOS
Mri Devices Corp.
Radiology · 67d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · FET
Smith & Nephew, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 02, 2001
CLEAN SCRAPE
K003773 · GEI
Webb Research Ii, Inc.
General & Plastic Surgery · 58d
Cleared Feb 02, 2001
OPDIMA
K003945 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037 · JAA
Karl Storz Endoscopy
Radiology · 36d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057 · LNH
Biosound Esaote, Inc.
Radiology · 25d
Cleared Feb 02, 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · GZJ
Johari Electro-Tech Co.
Neurology · 494d
Cleared Feb 01, 2001
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K002042 · HGI
New England Medical Corp.
Obstetrics & Gynecology · 211d
Cleared Feb 01, 2001
PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
K002688 · CGA
Lxn Corp.
Chemistry · 156d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 90d
Cleared Feb 01, 2001
SUCTION IRRIGATOR
K003443 · FHF
Applied Medical
Gastroenterology & Urology · 87d
Cleared Feb 01, 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Feb 01, 2001
PROCLUDE-SENSITIVE
K003482 · LBH
Ortek Therapeutics, Inc.
Dental · 84d
Cleared Feb 01, 2001
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
K003615 · FKP
Environmental Test Systems, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 01, 2001
EYETECT TREMOR MONITOR UNIT (TMU)
K003644 · GWN
Eyetect, LLC
Neurology · 66d
Cleared Feb 01, 2001
KAPPA IMMAGE FREELITE KIT
K003669 · DFH
The Binding Site, Ltd.
Immunology · 65d
Cleared Feb 01, 2001
LAMBDA IMMAGE FREELITE KIT
K003671 · DEH
The Binding Site, Ltd.
Immunology · 65d
Cleared Feb 01, 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM...
K003737 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 59d
Cleared Feb 01, 2001
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
K003840 · FYD
I.C Medical, Inc.
General Hospital · 51d
Cleared Feb 01, 2001
FLEXTIME MAGNUM 360
K003930 · ELW
Heraeus Kulzer, Inc.
Dental · 43d
Cleared Feb 01, 2001
M2376A DEVICELINK SYSTEM
K010048 · MWI
Agilent Technologies, Inc.
Cardiovascular · 27d
Cleared Feb 01, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 24d