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
41185–41208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR
K130917 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 51d
Cleared May 24, 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared May 24, 2013
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
K131019 · JWH
Conformis, Inc.
Orthopedic · 42d
Cleared May 24, 2013
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K131088 · IYN
Sonoscape Company Limited
Radiology · 36d
Cleared May 24, 2013
LANX SPINAL FIXATION SYSTEM
K131156 · KWP
Lanx, Inc.
Orthopedic · 30d
Cleared May 24, 2013
TERASON USMART3200T ULTRASOUND SYSTEM
K131209 · IYN
Teratech Corp.
Radiology · 25d
Cleared May 24, 2013
CORONIS 3MP
K131246 · LLZ
Barco N.V.
Radiology · 23d
Cleared May 23, 2013
SANICLAVE 102, MODEL RS-SC-102
K122978 · FLE
Alternative Pioneering Research and...
General Hospital · 239d
Cleared May 23, 2013
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP...
K123084 · FMG
Elcam Medical Acal
General Hospital · 234d
Cleared May 23, 2013
ATOM TRANSCAPSULE V-707
K123937 · FPL
Atom Medical Corporation
General Hospital · 154d
Cleared May 23, 2013
DISCOVERY MR750W 3.0T
K130115 · LNH
Ge Medical Systems, LLC
Radiology · 127d
Cleared May 23, 2013
IVAS 10MM AND 15MM BALLOON CATHETER
K130430 · HRX
Stryker Corporation
Orthopedic · 92d
Cleared May 22, 2013
GETINGE 800HC- SERIES STEAM STERILIZER
K122625 · FLE
Getinge Sourcing, LLC
General Hospital · 267d
Cleared May 22, 2013
BARLE TISSUE ADHESIVE
K123133 · MPN
Advanced Medical Solutions...
General & Plastic Surgery · 230d
Cleared May 22, 2013
THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
K123662 · GEI
Justright Surgical, LLC
General & Plastic Surgery · 175d
Cleared May 22, 2013
H-30 HOLMIUM LASER SYSTEM
K130444 · GEX
Cook, Inc.
General & Plastic Surgery · 90d
Cleared CT May 22, 2013
BREATHID HP SYSTEM
K130524 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 83d
Cleared May 22, 2013
WINX SLEEP THERAPY SYSTEM
K130538 · OZR
Apnicure, Inc.
Anesthesiology · 82d
Cleared May 22, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K130551 · OQW
Centers For Disease Control and...
Microbiology · 79d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · EZN
Boston Scientific Corporation
Gastroenterology & Urology · 58d
Cleared May 22, 2013
ANYTHINK PACS WORKSTATION
K131299 · LLZ
Beijing Crealife Technology Co., Ltd.
Radiology · 15d
Cleared May 21, 2013
TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
K122214 · CCK
Nihon Kohden Corp.
Anesthesiology · 300d
Cleared May 21, 2013
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
K122519 · DZE
Dio Corporation
Dental · 277d
Cleared May 21, 2013
HUMICARE D900
K122705 · BTT
Grundler GmbH
Anesthesiology · 259d