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
91537–91560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1997
XPLAN-1
K972905 · IYE
Radionics Software Applications, Inc.
Radiology · 83d
Cleared Oct 28, 1997
HELIOS LASER IMAGER 1417
K973028 · LMC
Sterling Diagnostic Imaging, Inc.
Radiology · 75d
Cleared Oct 28, 1997
MEDSTATION
K973090 · LMD
Program S.R.L.
Radiology · 71d
Cleared Oct 28, 1997
UBI MAGIWEL AMPHETAMINE METABOLITES
K973153 · DJG
United Biotech, Inc.
Toxicology · 67d
Cleared Oct 28, 1997
UBI MAGIWEL OPIATE METABOLITES
K973155 · DJG
United Biotech, Inc.
Toxicology · 67d
Cleared Oct 28, 1997
UBI MAGIWEL COCAINE METABOLITES
K973156 · DJG
United Biotech, Inc.
Toxicology · 67d
Cleared Oct 28, 1997
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
K973422 · LMC
Dejarnette Research Systems
Radiology · 48d
Cleared Oct 28, 1997
LASETTE
K973431 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 48d
Cleared Oct 28, 1997
AM SERIES HEARING AID
K973579 · ESD
A & M Hearing, Ltd.
Ear, Nose, Throat · 39d
Cleared Oct 28, 1997
DUALINE 100 BTE
K973948 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 12d
Cleared Oct 27, 1997
URO MED NERVE STIMULATOR
K970971 · ETN
Uromed Corp.
Ear, Nose, Throat · 224d
Cleared Oct 27, 1997
COMBIPORT FLUID LAVAGE DEVICE
K971259 · KDH
B.Braun Medical, Inc.
Gastroenterology & Urology · 206d
Cleared Oct 27, 1997
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET
K971313 · FJK
National Medical Care, Inc.
Gastroenterology & Urology · 201d
Cleared Oct 27, 1997
BRAINSCAN CONFORMAL RT MODULE
K971367 · IYE
Brainlab AG
Radiology · 196d
Cleared Oct 27, 1997
HYDRAGEL 7,15,30, CHOL-HDL KIT
K972015 · LBT
Morax
Chemistry · 150d
Cleared Oct 27, 1997
SPIFE
K972274 · CEF
Helena Laboratories
Chemistry · 131d
Cleared Oct 27, 1997
RAPID FIRE HAIR IMPLANTER CAROUSEL
K972918 · GAH
Apex Medical Products, LLC
General & Plastic Surgery · 81d
Cleared Oct 27, 1997
SUPER SILIPLUGS EAR PLUGS
K972923 · EWD
Interview Medical Technology Corp.
Ear, Nose, Throat · 80d
Cleared Oct 27, 1997
VOX/BASE FOR WINDOWS
K972933 · LLZ
J-Mac System, Inc.
Radiology · 80d
Cleared Oct 27, 1997
MODEL C-1 HEARING AID
K973043 · ESD
Better Hearing, Inc.
Ear, Nose, Throat · 73d
Cleared Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
K973098 · JDQ
Plus Orthopedics
Orthopedic · 69d
Cleared Oct 27, 1997
MIDAS TOUCH ELECTROSURGICAL ELECTRODE
K973234 · GEI
Iti Medical Technologies, Inc.
General & Plastic Surgery · 60d
Cleared Oct 27, 1997
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · CEP
Armkel, LLC
Chemistry · 54d
Cleared Oct 27, 1997
BRAND NAME *1-STEP PREGNANCY
K973352 · LCX
Armkel, LLC
Chemistry · 52d