BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    MEDELA BATTERY OPERATED BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRU RP Implant 4.3X8MM, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107290·The TRU is a self-tapping, double thread screw ...

    OnBrace Crown LL7 (5/pk)

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199013440·

    24PW - Hanta Virus

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White

    G+ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVIA IMS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·November 9, 2010

    Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code LXH·April 13, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021