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
80113–80136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2000
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM)...
K001927 · DSY
Thoratec Laboratories Corp.
Cardiovascular · 175d
Cleared Dec 18, 2000
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920 · HKI
Escalon Medical Corp.
Ophthalmic · 90d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923 · LXT
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 18, 2000
EHC400 DESKTOP PATIENT STATION
K002984 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 84d
Cleared Dec 18, 2000
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
K002999 · GAW
Gramsmed, LLC
General & Plastic Surgery · 83d
Cleared Dec 18, 2000
GRAMS NYLON NONABSORBABLE SUTURE
K003000 · GAR
Gramsmed, LLC
General & Plastic Surgery · 83d
Cleared Dec 18, 2000
MODIFICATION TO VNUS CLOSURE SYSTEM
K003092 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · LCP
Roche Diagnostics Corp.
Hematology · 74d
Cleared Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
K003158 · JHW
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Dec 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K003622 · MWI
Agilent Technologies, Inc.
Cardiovascular · 24d
Cleared Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K003721 · JJE
Olympus America, Inc.
Chemistry · 14d
Cleared Dec 18, 2000
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
K993406 · ITI
Permobil AB
Physical Medicine · 437d
Cleared Dec 15, 2000
AIW WATER SYSTEM FOR HEMODIALYSIS
K001282 · FIP
American Industrial Water
Gastroenterology & Urology · 238d
Cleared Dec 15, 2000
QUICKIE 2 POWER ASSIST WHEELCHAIR
K001491 · ITI
Sunrise Medical, Inc.
Physical Medicine · 217d
Cleared Dec 15, 2000
M-XX OXYGEN SENSORS
K002384 · CCL
International Business Strategies
Anesthesiology · 133d
Cleared Dec 15, 2000
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · KWP
Depuyacromed
Orthopedic · 105d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · LPH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052,...
K002906 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Dec 15, 2000
MTG - MINITUB HEATED STAGE SYSTEMS
K002971 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 15, 2000
MEROGEL CONTROL GEL ENT SURGICAL DRESSING
K002972 · KHJ
Medtronic Xomed
Ear, Nose, Throat · 84d
Cleared Dec 15, 2000
GRAMS SILK NONABSORBABLE SUTURE
K003001 · GAP
Gramsmed, LLC
General & Plastic Surgery · 80d
Cleared Dec 15, 2000
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
K003015 · GAN
Surgical Specialties Corp
General & Plastic Surgery · 79d
Cleared Dec 15, 2000
TITAN TIBIAL NAIL
K003018 · HSB
Howmedica Osteonics Corp.
Orthopedic · 79d
Cleared Dec 15, 2000
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE,...
K003038 · OLW
Agilent Technologies Deutschland GmbH
Neurology · 77d