BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Silicone MCP

    FDA UDI
    Stryker GmbH·00886385021966·Starter Awl

    GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OLYMPUS CK-MB REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MINIMAX STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

    MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019

    UNKNOWN SHOULDER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·October 14, 2014

    KIT 45CM PERMCATH

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·June 7, 2013

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·January 8, 2020

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 15, 2020

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024