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
57601–57624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2008
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
K072736 · ETN
Rhythmlink International, LLC
Ear, Nose, Throat · 117d
Cleared Jan 22, 2008
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
K072762 · HIB
Depalt, Inc.
Obstetrics & Gynecology · 116d
Cleared Jan 22, 2008
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
K072770 · LDF
Oscor, Inc.
Cardiovascular · 116d
Cleared Jan 22, 2008
BOSTON-BAND CRANIAL REMODLING ORTHOSIS
K072862 · OAN
Boston Brace Intl., Inc.
Neurology · 109d
Cleared Jan 22, 2008
NIO 5MP DISPLAY, MODEL E5620
K072875 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 105d
Cleared Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
K073093 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 82d
Cleared Jan 22, 2008
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 48d
Cleared Jan 22, 2008
SYNOCTA ABUTMENTS
K073628 · NHA
Straumann USA
Dental · 27d
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jan 18, 2008
NICOM ELECTRODES
K071631 · DXG
Cheetah Medical, Inc.
Cardiovascular · 218d
Cleared Jan 18, 2008
BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES
K072124 · GEI
Black & Black Surgical, Inc.
General & Plastic Surgery · 169d
Cleared Jan 18, 2008
CYTOPHIL TISSUE MARKER
K072219 · NEU
Cytophil, Inc.
General & Plastic Surgery · 161d
Cleared Jan 18, 2008
ENTERAL FEEDING SPIKE ADAPTER
K072652 · KNT
Cedic S.R.L.
Gastroenterology & Urology · 120d
Cleared Jan 18, 2008
MODIFICATION TO THERMAGE THERMACOOL SYSTEM
K072849 · GEI
Thermage, Inc.
General & Plastic Surgery · 106d
Cleared Jan 18, 2008
PATRIOT SPACERS
K072970 · MAX
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jan 18, 2008
PATRIOT SPACERS: COLONIAL ACDF
K072991 · ODP
Globus Medical, Inc.
Orthopedic · 87d
Cleared Jan 18, 2008
MICROMRI WRIST COIL
K073131 · MOS
Micromri, Inc.
Radiology · 73d
Cleared Jan 18, 2008
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
K073292 · LLZ
Heeyoung Co., Ltd.
Radiology · 56d
Cleared Jan 18, 2008
OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL
K073310 · MOS
Hitachi Medical Corp.
Radiology · 56d
Cleared Jan 18, 2008
DERMAPAL WITH DIGITAL TIMER
K073587 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 29d
Cleared Jan 17, 2008
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
K071456 · MAI
Arthrex, Inc.
Orthopedic · 237d
Cleared Jan 17, 2008
CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1
K072635 · FLL
Ningbo Huahui Medical Instruments...
General Hospital · 121d
Cleared Jan 17, 2008
TENDER ORTHO BOND-ENA BOND-ENA ETCH
K072978 · DYH
Micerium S.P.A.
Dental · 87d
Cleared Jan 17, 2008
AURAVENEER CEMENT
K073101 · EMA
Denali Corporation
Dental · 93d