BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    BAUER TEMNO BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESOLVE

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750007691·0.8% RESOLVE PANEL C 22X3ML

    STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387

    FDA 510(k)
    FDA Class 2 ·Dental

    PURILENS SALINE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 54

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 18, 2019

    HI-TORQUE WHISPER GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-MURRIETA·Product code DQX·November 11, 2010

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2013

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·AMERICAN OPTISURGICAL, INC.·Product code LFL·February 24, 2014

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code QHT·May 5, 2022

    0.8% RESOLVE C 22X3ML

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code QHT·June 18, 2025

    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-002. ev3 IntraStent LD Max Large Diameter Peripheral Stent, Model Number: S18-36, Catalog Number: 90-2337-002. (not approved within USA)

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, Catalog Number: 90-2337-000 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-001. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within USA).

    FDA Recall
    Terminated ·Product code FGE·January 18, 2008

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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