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
80425–80448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2001
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
K003231 · GZJ
Home Medical Services
Neurology · 87d
Cleared Jan 12, 2001
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · JDC
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 12, 2001
MS-ONE, MODEL MS-1
K003258 · GZJ
Home Wellness West
Neurology · 86d
Cleared Jan 12, 2001
E.N.S.I. RETRACTABLE SAFETY SYRINGE
K003348 · MEG
Ensi-Med International Pty. , Ltd.
General Hospital · 78d
Cleared Jan 12, 2001
GUARDED NEEDLE 2000
K003406 · FMI
International Medical Device...
General Hospital · 72d
Cleared Jan 12, 2001
MPS ACACIA PAIN KIT
K003476 · MEB
Mps Acacia
General Hospital · 64d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · JTN
Hardy Diagnostics
Microbiology · 43d
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