BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540257741·BOLT DRIVER FOR PIN CLAMP

    Endura Plus Instruments

    FDA UDI
    Ortho Organizers, Inc.·00190707089061·Endura® Plus™ Mathieu Hook Tip

    OneLIF™

    FDA UDI
    Novapproach Spine LLC·G07001312011180·Retention Plate, Anterior-Only, Small, 11 mm - ...

    ESOP®

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489011184·

    MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

    FDA 510(k)
    FDA Class 2 ·Neurology

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    BD PHASEAL¿ PROTECTOR P50

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 29, 2022

    Widex

    FDA UDI
    Widex A/S·05706069710373·Widex EVOKE E-FS (Tech Black ) Telecoil, RC coil

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·January 17, 2007

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 27, 2014

    NONE

    FDA Adverse Event
    Death ·WILLIAM COOK AUSTRALIA·Product code MIH·June 27, 2013

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·July 29, 2011

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021