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
39457–39480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2013
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130611 · KNT
Xeridiem Medical Devices
Gastroenterology & Urology · 287d
Cleared Dec 19, 2013
ELISIO-H HEMODIALYZER
K131381 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 219d
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW
ACON Laboratories, Inc.
Chemistry · 167d
Cleared Dec 19, 2013
VAPOR CERAMIC BRACKET
K132368 · NJM
Orthodontic Design and Production, Inc.
Dental · 142d
Cleared Dec 19, 2013
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · JIT
Biokit, S.A.
Chemistry · 140d
Cleared Dec 19, 2013
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
K132623 · DQX
Medtronic
Cardiovascular · 119d
Cleared Dec 19, 2013
SMARTVEST AIRWAY CLEARANCE SYSTEM
K132794 · BYI
Electromed, Inc.
Anesthesiology · 104d
Cleared Dec 19, 2013
LINA POWERBLADE PLUS
K132837 · GEI
Lina Medical Aps
General & Plastic Surgery · 100d
Cleared Dec 19, 2013
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · HCG
MicroVention, Inc.
Neurology · 91d
Cleared Dec 19, 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · NBW
I-Sens, Inc.
Chemistry · 50d
Cleared Dec 19, 2013
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · KWQ
Nexxt Spine, LLC
Orthopedic · 37d
Cleared Dec 19, 2013
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
K133511 · LLZ
Jvckenwood Corporation
Radiology · 35d
Cleared Dec 19, 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
K133561 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 29d
Cleared Dec 18, 2013
LUCO HYBRID OSA APPLIANCE
K130797 · LRK
Luco Hybrid Osa Appliance, Inc.
Dental · 271d
Cleared Dec 18, 2013
EARLYSENSE
K131379 · BZQ
Earlysense, Ltd.
Anesthesiology · 218d
Cleared Dec 18, 2013
COPRA TEMP PMMA-DISK
K131664 · EBG
White Peaks Dental Systems GmbH & Co. KG
Dental · 194d
Cleared Dec 18, 2013
SURGEN U
K131758 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 184d
Cleared Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
K132186 · HKI
Optomed OY
Ophthalmic · 156d
Cleared Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418 · JGS
Roche Diagnostics
Chemistry · 138d
Cleared Dec 18, 2013
ARIX HAND LOCKING SYSTEM
K132876 · HRS
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 18, 2013
M.U.S.T. EXTENSION
K132878 · NKB
Medacta International
Orthopedic · 96d
Cleared Dec 18, 2013
TI STAR IMPLANT SYSTEM
K132992 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 85d
Cleared Dec 18, 2013
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
K133440 · HWC
Stryker Trauma AG
Orthopedic · 36d
Cleared Dec 18, 2013
APTUS CANNULATED COMPRESSION SCREWS
K133460 · HWC
Medartis AG
Orthopedic · 36d