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
67561–67584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2004
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
K042475 · CFN
Ortho-Clinical Diagnostics, Inc.
Immunology · 58d
Cleared Nov 10, 2004
ACCUPACH V
K042752 · IYO
Accutome Ultrasound, Inc.
Radiology · 37d
Cleared Nov 10, 2004
TRAUMACAD 1.2
K042816 · LLZ
Orthocrat, Ltd.
Radiology · 29d
Cleared Nov 10, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF,...
K042853 · DXN
Health & Life Co., Ltd.
Cardiovascular · 26d
Cleared Nov 10, 2004
DEMETRON IDS CURING LIGHT
K042888 · EBZ
Kerr Corp.
Dental · 22d
Cleared Nov 10, 2004
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
K043018 · DXN
Omron Healthcare, Inc.
Cardiovascular · 8d
Cleared Nov 09, 2004
SPIRALOK ANCHOR
K041069 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 09, 2004
FASTIN RC ANCHOR
K041075 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · LZO
Howmedica Osteonics Corp.
Orthopedic · 189d
Cleared Nov 09, 2004
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
K042029 · LPH
Biomet, Inc.
Orthopedic · 104d
Cleared Nov 09, 2004
SURGICHIP TAG SURGICAL MARKER
K042555 · FZZ
Surgichip, Inc.
General & Plastic Surgery · 50d
Cleared Nov 09, 2004
TETRIC EVOCERAM
K042819 · EBF
Ivoclar Vivadent, Inc.
Dental · 28d
Cleared Nov 09, 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · LZO
Exactech, Inc.
Orthopedic · 26d
Cleared Nov 09, 2004
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
K042851 · OTN
Mentor Corp.
Gastroenterology & Urology · 25d
Cleared Nov 09, 2004
ENTERYX INJECTION CATHETER
K042882 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Nov 09, 2004
GEMINI GXL
K042935 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Nov 09, 2004
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
K042949 · PAG
C.R. Bard, Inc.
Gastroenterology & Urology · 14d
Cleared Nov 08, 2004
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
K041239 · KZE
Genesis Medical Technology, Inc.
General Hospital · 181d
Cleared Nov 08, 2004
SONX 35 ULTRASONIC BLEACHING SYSTEM
K041392 · EEG
CAO Group, Inc.
Dental · 167d
Cleared Nov 08, 2004
POLARIS DS/COMET
K041959 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 110d
Cleared Nov 08, 2004
SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
K042153 · EEG
Dentovations, Inc.
Dental · 91d
Cleared Nov 08, 2004
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
K042211 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Nov 08, 2004
BEELINE MOTIV, PROPOLIS, PCA
K042228 · FRN
Mckinley, Inc.
General Hospital · 83d
Cleared Nov 08, 2004
SUPERDIMENSION/BRONCHUS
K042438 · JAK
Superdimension, Ltd.
Radiology · 61d