BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994325778·CONNECTOR 7042230 LAT CONN TI 4.5 32MM

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871012·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    23GA Illuminating Laser Probe, SMA905

    FDA UDI
    Peregrine Surgical, Llc·00632307002083·23GA Illuminating Laser Probe, SMA905

    CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 9, 2013

    MOST STEM DISTRACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HAW·February 15, 2011

    INSIGNIA ENTRA

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    COMPREHENISVE HYBRID GLENOID BASE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·June 13, 2018

    COMPREHENSIVE HYBRID GLENOID POST REGENEREX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·June 13, 2018

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019