BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    PUMA-G System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515027336·Weitlaner Ret, blunt prng 3x4, 9.5"

    I-MAX TOUCH

    FDA 510(k)
    FDA Class 2 ·Dental

    ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEM EXTENSION

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

    LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

    2520274-2013-03517

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·June 21, 2013

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 28, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 17, 2014

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018