BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Conform Resorbable Collagen Membrane

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950007288·CONFORM COLLAGEN DENTAL MEMBRANE 15X20MM RESORB...

    conFORM

    FDA UDI
    COLLAGEN MATRIX, INC.·00813954027852·Resorbable Collagen Membrane

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122186·KWire .035x6" (0.9x150mm)

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122179·KWire .035x6" (0.9x150mm) Threaded

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115200·Needle, Bevel Stylet, Stainless Steel, Disposable

    ALPHA OMEGA DUAL COOLER-HEATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE-X

    FDA 510(k)
    FDA Class 2 ·Dental

    UNK MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·July 20, 2022

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    SPACEMAKER BLUNT TIP

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·August 20, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 17, 2011

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·May 7, 2019

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·July 14, 2017

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

    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