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
70297–70320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2004
INTUITION IMAGE
K032511 · LHN
Brainlab AG
Radiology · 160d
Cleared Jan 21, 2004
TRISTAR AESTHETIC WORKSTATION LASER
K033176 · GEX
Cynosure, Inc.
General & Plastic Surgery · 112d
Cleared Jan 21, 2004
AMERSHAM HEALTH NEEDLE-GUARD
K033409 · FMI
Gettig Pharmaceutical Instrument Co.
General Hospital · 89d
Cleared Jan 21, 2004
VARIFLEX
K033632 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 63d
Cleared Jan 21, 2004
IDEIA PCE CHLAMYDIA
K033865 · LJC
Dakocytomation, Ltd.
Microbiology · 40d
Cleared Jan 21, 2004
POLY PER-Q-CATH PICC CATHETERS
K034019 · LJS
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 21, 2004
GROSHONG NXT PICC CATHETERS
K034020 · LJS
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 21, 2004
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
K034031 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 23d
Cleared Jan 21, 2004
ESPRIT VENTILATOR, MODEL V1000
K034040 · CBK
Respironics, Inc.
Anesthesiology · 23d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055 · JHX
Diagnostic Products Corp.
Chemistry · 22d
Cleared Jan 21, 2004
MODIFICATION TO PRISMALIX SURGICAL LIGHT
K040015 · FSY
Alm S.A.
General & Plastic Surgery · 16d
Cleared Jan 20, 2004
GII SPINAL FIXATION SYSTEM
K032604 · MNH
Co-Ligne AG
Orthopedic · 148d
Cleared Jan 20, 2004
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
K032641 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 146d
Cleared Jan 20, 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · HKX
Reichert, Inc.
Ophthalmic · 133d
Cleared Jan 20, 2004
SPHINX LASER SYSTEMS
K033437 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 84d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · KTT
Howmedica Osteonics Corp.
Orthopedic · 78d
Cleared Jan 20, 2004
MRJ
K033507 · LNH
Paramed S.R.L.
Radiology · 76d
Cleared Jan 20, 2004
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
K033744 · MVM
Hycor Biomedical , Ltd.
Immunology · 50d
Cleared Jan 20, 2004
ONTRAK TESTCUP II AND ONSITE CUPKIT
K033902 · DKZ
Varian, Inc.
Toxicology · 34d
Cleared Jan 20, 2004
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
K033956 · KPS
Is2 Research, Inc.
Radiology · 29d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 14d
Cleared Jan 16, 2004
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
K030341 · CBK
eVent Medical, Ltd.
Anesthesiology · 347d
Cleared Jan 16, 2004
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
K031617 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 238d
Cleared Jan 16, 2004
DUREX PLAY LUBRICANT
K032124 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 190d