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
91945–91968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1997
HYDROCHECK MICRO FILTER
K970488 · HGX
White River Concepts
Obstetrics & Gynecology · 267d
Cleared Nov 04, 1997
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
K970853 · DRF
Cardima, Inc.
Cardiovascular · 242d
Cleared Nov 04, 1997
VISTA EYESHOWER
K971134 · LXQ
John Branch
Anesthesiology · 221d
Cleared Nov 04, 1997
MUMPS IGG ELISA TESTY
K971857 · LJY
Gull Laboratories, Inc.
Microbiology · 168d
Cleared Nov 04, 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 120d
Cleared Nov 04, 1997
CONTROL SYRINGE
K972655 · IZI
Medical Specialties Intl., Inc.
Radiology · 112d
Cleared Nov 04, 1997
IL TEST D-DIMER
K972696 · DAP
Instrumentation Laboratory CO
Hematology · 109d
Cleared Nov 04, 1997
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
K972903 · JAK
Imatron, Inc.
Radiology · 90d
Cleared Nov 04, 1997
STELKAST BIPOLAR SYSTEM
K972961 · JDI
Stelkast Company
Orthopedic · 85d
Cleared Nov 04, 1997
VENTRAL WALL DEFECT REDUCTION SILO
K973082 · FTL
Specialty Surgical Products, Inc.
General & Plastic Surgery · 78d
Cleared Nov 04, 1997
NIDEK HANDY
K973218 · HKI
Nidek, Inc.
Ophthalmic · 69d
Cleared Nov 04, 1997
RODENSTOCK LASER SLITLAMP
K973220 · HQF
G. Rodenstock Instrumente GmbH
Ophthalmic · 69d
Cleared Nov 04, 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S,...
K973226 · ETD
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 69d
Cleared Nov 04, 1997
IL TEST APTT-SP
K973306 · GFO
Instrumentation Laboratory CO
Hematology · 62d
Cleared Nov 04, 1997
ACE PHENYTOIN REAGENT, AED CALIBRATORS
K973414 · DIP
Schiapparelli Biosystems, Inc.
Toxicology · 56d
Cleared Nov 04, 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533 · HKI
Nidek, Inc.
Ophthalmic · 47d
Cleared Nov 04, 1997
MAGNATONE / STERLING/ ST
K973665 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 40d
Cleared Nov 04, 1997
OSOM CARD HCG-URINE TEST
K973879 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 55d
Cleared Nov 04, 1997
OTICON DIGISOUND ITE
K973885 · ESD
Oticon, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
OTICON DIGISOUND COMPACT
K973886 · ESD
Oticon, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 04, 1997
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · JIY
Diagnostic Chemicals , Ltd.
Chemistry · 20d
Cleared Nov 04, 1997
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC,...
K973972 · ESD
Perfect Ear
Ear, Nose, Throat · 15d
Cleared Nov 04, 1997
ELECSYS CALLCHECK DIGOXIN
K973973 · DMP
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Nov 04, 1997
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000 · JQB
Diagnostic Chemicals , Ltd.
Chemistry · 14d