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
46897–46920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2011
VENNER TRACHEAL SEAL MONITOR
K110631 · BSK
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 146d
Cleared Jul 28, 2011
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
K110723 · NLF
Masimo Corporation
Anesthesiology · 134d
Cleared Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · JDQ
Synthes (Usa)
Orthopedic · 128d
Cleared Jul 28, 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000 · HWC
Parcus Medical, LLC
Orthopedic · 108d
Cleared Jul 28, 2011
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
K111191 · CBP
Wet Nose Technologies, LLC
Anesthesiology · 91d
Cleared Jul 28, 2011
SMR SHOULDER SYSTEM- REVISION STEMS
K111212 · KWS
Lima Corporate S.P.A.
Orthopedic · 90d
Cleared Jul 28, 2011
MRI-Q SYSTEM
K111222 · LLZ
Resonance Health Analysis Services...
Radiology · 87d
Cleared Jul 28, 2011
SNAP (R) WOUND CARE SYSTEM
K111393 · OKO
Spiracur, Inc.
General & Plastic Surgery · 71d
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400 · JWH
Exactech, Inc.
Orthopedic · 70d
Cleared Jul 28, 2011
INTELLISPACE PACS 4.X
K111804 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 31d
Cleared Jul 28, 2011
BIOPSY VALVE
K111821 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 28, 2011
VITREAVIEW SOFTWARE 6.1
K111892 · LLZ
Vital Images, Inc.
Radiology · 23d
Cleared Jul 27, 2011
TISSUE SAMPLING NEEDLE
K103694 · FCG
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 222d
Cleared Jul 27, 2011
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
K110156 · DXN
Contec Medical System Co., Ltd.
Cardiovascular · 189d
Cleared Jul 27, 2011
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
K110546 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 152d
Cleared Jul 27, 2011
BD AUTOSHIELD DUO PEN NEEDLE
K110703 · FMI
Becton, Dickinson and Company
General Hospital · 135d
Cleared Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · HQB
Nidek Co., Ltd.
Ophthalmic · 57d
Cleared Jul 27, 2011
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS...
K111517 · KZE
Pharmajet, Inc.
General Hospital · 55d
Cleared Jul 27, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K111752 · LYZ
Shandong Jianhong New Material Company
General Hospital · 35d
Cleared Jul 27, 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA...
K111972 · KFM
Medtronic, Inc.
Cardiovascular · 16d
Cleared Jul 26, 2011
ADVANCIS ACTIVON TUBE
K101114 · FRO
Advancis Medical
General & Plastic Surgery · 461d
Cleared Jul 26, 2011
APEX SPINE SYSTEM
K110906 · NKB
Spinecraft, LLC
Orthopedic · 117d
Cleared Jul 26, 2011
PICA WHOLE-BODY MRI SYSTEM
K110942 · LNH
Time Medical Limited
Radiology · 113d
Cleared Jul 26, 2011
PATCH, PLEDGET AND INTRACARDIAC
K111187 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 90d