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
91441–91464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 03, 1997
DYNA T-2000 PHYSICAL THERAPY SYSTEM
K955808 · IMB
Thermia, Inc.
Physical Medicine · 682d
Cleared Nov 03, 1997
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT...
K964926 · ILJ
Joerns Healthcare, Inc.
Physical Medicine · 329d
Cleared Nov 03, 1997
THEROX INFUSION GUIDEWIRES
K971719 · DQX
Therox, Inc.
Cardiovascular · 178d
Cleared Nov 03, 1997
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730 · KWQ
Depuy, Inc.
Orthopedic · 178d
Cleared Nov 03, 1997
PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES
K971912 · GEX
Xintec Corporation
General & Plastic Surgery · 206d
Cleared Nov 03, 1997
ERCO-VAC
K972537 · LKY
Ercons, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 03, 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893 · LZO
Howmedica Corp.
Orthopedic · 90d
Cleared Nov 03, 1997
KERBOULL CROSS
K972928 · JDI
Howmedica, Inc.
Orthopedic · 87d
Cleared Nov 03, 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE...
K972944 · DQX
Medtronics Interventional Vascular
Cardiovascular · 84d