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
92041–92064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1997
IMMUSURE
K973894 · JJY
Quantimetrix Corp.
Chemistry · 15d
Cleared Oct 29, 1997
2 GALLON ALTERNATE CARE SHARPS CONTAINER
K973911 · FMI
Sage Products, Inc.
General Hospital · 15d
Cleared Oct 28, 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · MBI
Howmedica Corp.
Orthopedic · 420d
Cleared Oct 28, 1997
CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
K970264 · DYB
Cordis Webster, Inc.
Cardiovascular · 278d
Cleared Oct 28, 1997
CHASE TEMPERATURE PROBE
K971013 · DTN
Chase Medical, Inc.
Cardiovascular · 222d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE-...
K972271 · KXK
Ml Strategies, Inc.
Radiology · 132d
Cleared Oct 28, 1997
ERCO-RIBBON
K972353 · LKY
Ercons, Inc.
Gastroenterology & Urology · 126d
Cleared Oct 28, 1997
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · DQA
Respironics, Inc.
Anesthesiology · 90d
Cleared Oct 28, 1997
DERMA K LASER SYSTEM
K972872 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 85d
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