BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    MULTICATH PLACEMENT KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Stern EX Acid Etched Implant RP 3.75x8.5mm, Direct Delivery, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549108815·The Sterngold Acid Etch Dental Implant System c...

    Navina™Consumable Set Cone

    FDA UDI
    Wellspect AB·07333387029016·Navina Transanal Irrigation. Consumable set con...

    Navina™Consumable Set Cone

    FDA UDI
    Wellspect AB·07392532243899·Navina Transanal Irrigation. Consumable set con...

    Esteem® EnvoyCem®

    FDA UDI
    Envoy Medical Corporation·00812282020368·EnvoyCem® Glass Ionomer Cement

    EnvoyCem®

    FDA UDI
    Envoy Medical Corporation·00812282020375·EnvoyCem® Glass Ionmer Cement

    BIOSOFT RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    DuraDiagnost

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN

    FDA Adverse Event
    WILLIAM COOK EUROPE·Product code DTK·October 27, 2015

    SELF RETAINING TORX DRIVER FOR 2.7 MM SURFIX NEWDEAL TIP

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HRS·May 6, 2014

    LINOX SMART TD 65/18

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code LWS·January 2, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 10, 2010

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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