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
54001–54024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2009
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
K083891 · JJY
Maine Standards Co.
Chemistry · 84d
Cleared Mar 23, 2009
CIRRUS OPEN
K090080 · LNH
Mri-Tech Sp. Zo.O.
Radiology · 70d
Cleared Mar 23, 2009
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
K090083 · LYC
Unicare Biomedical, Inc.
Dental · 70d
Cleared Mar 23, 2009
PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
K090286 · DXC
Advanced Vascular Dynamics
Cardiovascular · 46d
Cleared Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · HKI
Canon, Inc.
Ophthalmic · 30d
Cleared Mar 23, 2009
PHASEAL PROTECTOR P14, P21, P28 AND P50
K090634 · LHI
Carmel Pharma Ab.
General Hospital · 14d
Cleared Mar 23, 2009
DEVON ACCUBP CUFF
K090664 · DXQ
Devon Medical, Inc.
Cardiovascular · 10d
Cleared Mar 20, 2009
AVIE A1C TEST SYSTEM
K081269 · LCP
Mec Dynamics Corp
Chemistry · 319d
Cleared Mar 20, 2009
SYNCHRO HP PLATFORM
K082039 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 245d
Cleared Mar 20, 2009
BODYMETRIX BX2000
K082147 · OMV
Intelametrix, Inc.
Gastroenterology & Urology · 233d
Cleared Mar 20, 2009
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
K082689 · NGT
Spectra Medical Devices, Inc.
General Hospital · 186d
Cleared Mar 20, 2009
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
K082819 · NEY
Miramar Labs, Inc.
General & Plastic Surgery · 176d
Cleared Mar 20, 2009
NUVASIVE HELIX-T ACP SYSTEM
K083341 · KWQ
Nuvasive, Inc.
Orthopedic · 128d
Cleared Mar 20, 2009
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
K083425 · ODP
Adaptive Specialty, LLC
Orthopedic · 121d
Cleared Mar 20, 2009
MYOSCIENCE CRYO-TOUCH
K083493 · GEH
Myoscience, Inc.
General & Plastic Surgery · 115d
Cleared Mar 20, 2009
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
K083720 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 95d
Cleared Mar 20, 2009
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND...
K083802 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 88d
Cleared Mar 20, 2009
RES TRAXX ONLINE, MODEL: R14
K083816 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Mar 20, 2009
OSCAR BONE RESECTOR
K083830 · JDX
Orthosonics, Ltd.
Orthopedic · 87d
Cleared Mar 20, 2009
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
K083843 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Mar 20, 2009
STERIS CMAX XLT SURGICAL TABLE
K090136 · FQO
STERIS Corporation
General & Plastic Surgery · 58d
Cleared Mar 20, 2009
MODIFICATION TO: DSS STABILIZATION SYSTEM
K090408 · NKB
Paradigm Spine, LLC
Orthopedic · 30d
Cleared Mar 20, 2009
ALLURE MB CERAMIC BRACKETS
K090454 · NJM
Dentsply Interntional
Dental · 25d
Cleared Mar 20, 2009
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR,...
K090483 · DPS
Philips Medical Systems
Cardiovascular · 23d