Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81025–81048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2001
PATTERN RESIN
K003817 · EBG
GC America, Inc.
Dental · 36d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991 · KRX
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 12, 2001
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
K001259 · DZE
Basic Dental Implant Systems, Inc.
Dental · 268d
Cleared Jan 12, 2001
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K001775 · DRT
Zoe Medical, Inc.
Cardiovascular · 214d
Cleared Jan 12, 2001
GENUA MENOPAUSE MONITOR TEST KIT
K002450 · CGJ
Genua 1944, Inc.
Chemistry · 156d
Cleared Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · KHE
Enterix, Inc.
Hematology · 155d
Cleared Jan 12, 2001
GEON DIGITAL CLINICAL THERMOMETER
K003223 · FLL
Geon Corp.
General Hospital · 88d
Cleared Jan 12, 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · DZE
Lifecore Biomedical, Inc.
Dental · 88d
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