BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    Balloon Guiding Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    DEPUY SPINE, LLC·10705034000756·SPINAL INSTRUMENT STRAIGHT OSTEOTOME 9.53mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528129968·Lisfranc Targeting Guide

    SURGI-VISION PROSTATE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    CARELINK

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD.·Product code NVZ·August 11, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·October 17, 2008

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012