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

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176,076 results
81241–81264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 15, 2000
ALL TERRAIN WHEELCHAIR (ATW)
K003048 · IOR
Roll-Ability (Pty) , Ltd.
Physical Medicine · 77d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · GEX
Laserscope
General & Plastic Surgery · 66d
Cleared Dec 15, 2000
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC)...
K003161 · LPL
Les Laboratoires Blanchard
Ophthalmic · 66d
Cleared Dec 15, 2000
RYTHMIC AND RYTHMIC UV
K003170 · LPL
Essilor Intl.
Ophthalmic · 66d
Cleared Dec 15, 2000
TRANSFX ANGLED RODS
K003205 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared Dec 15, 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211 · LXT
Howmedica Osteonics Corp.
Orthopedic · 63d
Cleared Dec 15, 2000
M2A 32MM TAPER SYSTEM
K003363 · KWY
Biomet, Inc.
Orthopedic · 49d