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
79921–79944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2001
PORTABLE BREAST COMPRESSION DEVICE
K003775 · IYX
Pem Technologies
Radiology · 37d
Cleared Jan 12, 2001
MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER
K003783 · IOR
Medical Depot, Inc.
Physical Medicine · 36d
Cleared Jan 12, 2001
MADA WHEELCHAIRS
K003862 · IOR
Mada Medical Products, Inc.
Physical Medicine · 30d
Cleared Jan 12, 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · JPK
R&D Systems, Inc.
Hematology · 28d
Cleared Jan 12, 2001
CA 125 II CALCHECK
K003967 · JJX
Roche Diagnostics Corp.
Immunology · 21d
Cleared Jan 12, 2001
ELECSYS CA 125 II CALSET
K003969 · JIS
Roche Diagnostics Corp.
Immunology · 21d
Cleared Jan 12, 2001
CONTOUR LABRAL NAIL, MODEL 533520A
K003970 · MAI
Bionx Implants, Inc.
Orthopedic · 21d
Cleared Jan 12, 2001
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
K010011 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 10d
Cleared Jan 12, 2001
MAXIM KNEE SYSTEM
K010027 · JWH
Biomet, Inc.
Orthopedic · 9d
Cleared Jan 11, 2001
COSMED QUARK
K001174 · BZC
Cosmed Srl
Anesthesiology · 275d
Cleared Jan 11, 2001
OUTBACK CATHETER
K001577 · DQY
Lumend, Inc.
Cardiovascular · 234d
Cleared Jan 11, 2001
PENILE CONSTRICTOR RING
K001859 · LKY
Basic Solutions, LLC
Gastroenterology & Urology · 206d
Cleared Jan 11, 2001
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
K002056 · HCG
Micrus Corp.
Neurology · 189d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067 · DSK
Radi Medical Systems AB
Cardiovascular · 188d
Cleared Jan 11, 2001
MICROSTREAM EXTERNAL BATTERY CHARGER
K002163 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 177d
Cleared Jan 11, 2001
PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES
K002381 · FMF
Pentaferte, S.R.L.
General Hospital · 160d
Cleared Jan 11, 2001
LACTOSORB SCREW ANCHOR
K003273 · MAI
Biomet, Inc.
Orthopedic · 85d
Cleared Jan 11, 2001
FILAC FAS TEMP ELECTRONIC THERMOMETER
K003313 · FLL
The Kendall Company
General Hospital · 80d
Cleared Jan 11, 2001
BURN JEL PLUS
K003396 · MGQ
Water-Jel Technologies, LLC
General & Plastic Surgery · 71d
Cleared Jan 11, 2001
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
K003485 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 85d
Cleared Jan 11, 2001
TAXOL ADMINISTRATION SET
K003513 · FPA
Icu Medical, Inc.
General Hospital · 58d
Cleared Jan 11, 2001
AVANTE CURELIGHT
K003683 · EBZ
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · DQO
NuMED, Inc.
Cardiovascular · 23d