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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48385–48408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2011
VENTLAB 6000 SERIES HUMIDIFIER
K093617 · BTT
Ventlab Corp.
Anesthesiology · 430d
Cleared Jan 27, 2011
GC ORAL MOISTURIZING GEL
K101346 · LFD
GC America, Inc.
Dental · 259d
Cleared Jan 27, 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765...
K101459 · MAI
Smith & Nephew, Inc.
Orthopedic · 246d
Cleared Jan 27, 2011
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
K102363 · JOJ
Spsmedical Supply Corp.
General Hospital · 160d
Cleared Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · MQV
Synthes USA Products, LLC
Orthopedic · 128d
Cleared Jan 27, 2011
REDONDO-L
K103297 · MAX
Seaspine, Inc.
Orthopedic · 80d
Cleared Jan 27, 2011
4D MV-ASSESSMENT 2.0
K103782 · DQK
Tomtec Imaging Systems GmbH
Cardiovascular · 31d
Cleared Jan 26, 2011
KOWA NONMYD WX
K101628 · HKI
Kowa Co. , Ltd.
Ophthalmic · 230d
Cleared Jan 26, 2011
MODEL LTV 1100 VENTILATOR
K101643 · CBK
Care Fusion
Anesthesiology · 230d
Cleared Jan 26, 2011
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
K101807 · MNW
Stayhealthy, Inc.
Gastroenterology & Urology · 212d
Cleared Jan 26, 2011
NEODENT IMPLANT SYSTEM
K101945 · DZE
Jjgc Industria E Comercio DE...
Dental · 198d
Cleared Jan 26, 2011
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
K102101 · HCD
Surgivision, Inc.
Neurology · 183d
Cleared Jan 26, 2011
DISPOSABLE BLOOD PRESSURE CUF
K102792 · DXQ
Caremate Medical Device Co., Ltd.
Cardiovascular · 121d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Jan 26, 2011
CONSENSUS KNEE SYSTEM
K102927 · MBH
Consensus Orthopedics, Inc.
Orthopedic · 114d
Cleared Jan 26, 2011
FREQUENCER
K103176 · BYI
Dymedso, Inc.
Anesthesiology · 90d
Cleared Jan 26, 2011
TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
K103187 · JOW
Wildcat Medical, Inc.
Cardiovascular · 90d
Cleared Jan 26, 2011
PENUMBRA EMBOLIZATION COIL SYSTEM
K103305 · HCG
Penumbra, Inc.
Neurology · 78d
Cleared Jan 26, 2011
SEDECAL
K103522 · IZL
Sedecal., Sa.
Radiology · 56d
Cleared Jan 26, 2011
LEFORTE NEURO SYSTEM BONE PLATE
K103778 · JEY
Jeil Medical Corporation
Dental · 30d
Cleared Jan 26, 2011
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM
K103780 · MJN
Micrus Endovascular Corporation
Cardiovascular · 30d
Cleared Jan 26, 2011
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES...
K103800 · FLL
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 29d
Cleared Jan 26, 2011
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
K110004 · OTJ
Advanced Surgical Concepts
General & Plastic Surgery · 23d
Cleared Jan 26, 2011
OMNIVISION
K110040 · LLZ
Modern Module, Inc.
Radiology · 20d