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
60793–60816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2006
ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE
K062277 · NHA
Atlantis Components, Inc.
Dental · 135d
Cleared Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353 · MQV
Integra LifeSciences Corporation
Orthopedic · 131d
Cleared Dec 20, 2006
CORTISOL ELISA
K062626 · CGR
Ibl-Hamburg GmbH
Chemistry · 106d
Cleared Dec 20, 2006
DPILOG, MODEL DPC-512
K062811 · CAF
Life Outcomes, Inc.
Anesthesiology · 92d
Cleared Dec 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY...
K062841 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Dec 20, 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 77d
Cleared Dec 20, 2006
AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
K063015 · DJG
Ameditech, Inc.
Toxicology · 79d
Cleared Dec 20, 2006
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
K063068 · NBW
Arkray USA, Inc.
Chemistry · 75d
Cleared Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND...
K063072 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K063073 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
K063616 · LZO
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · KRD
Cook, Inc.
Cardiovascular · 15d
Cleared Dec 20, 2006
XCEL 255 SLIT LAMP
K063750 · HJO
Reichert, Inc.
Ophthalmic · 1d
Cleared Dec 19, 2006
X-STEN MILD TOOL KIT, MODEL MTK-0001
K062038 · HRX
X-Sten Corp.
Orthopedic · 153d
Cleared Dec 19, 2006
SUNSPOTS PRE-GELLED SURFACE ELECTRODES
K062198 · GXY
Axon Systems, Inc.
Neurology · 140d
Cleared Dec 19, 2006
MODEL 2200
K062635 · ILY
Clarimedex, Inc.
Physical Medicine · 104d
Cleared Dec 19, 2006
RUIKE, MODEL 3431
K062645 · INI
Shanghai Ruike Sports Goods Co., Ltd.
Physical Medicine · 104d
Cleared Dec 19, 2006
U-CLIP DEVICE
K062821 · FZP
Medtronic Neurosurgery
General & Plastic Surgery · 90d
Cleared Dec 19, 2006
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · KWQ
Globus Medical, Inc.
Orthopedic · 90d
Cleared Dec 19, 2006
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE...
K062838 · MMI
Ortho-Clinical Diagnostics
Chemistry · 89d
Cleared Dec 19, 2006
NOBELPERFECT CONICAL CONNECTION
K062936 · DZE
Nobel Biocare AB
Dental · 82d
Cleared Dec 19, 2006
NEEDLELESS SLING
K063136 · PAH
Specialities Remeex International, S.L.
Gastroenterology & Urology · 64d
Cleared Dec 19, 2006
REST ASSURED NITE PROTECTOR
K063229 · OBR
Ranir, LLC
Dental · 55d
Cleared Dec 19, 2006
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K063331 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 46d