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

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    ZIRACE

    FDA 510(k)
    FDA Class 2 ·Dental

    Young

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302730515015·Young Junior Prophy Cup, Firm, Medium, White We...

    Resusa-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043515013·

    Cytoflex Ti-enforced

    FDA UDI
    UNICARE BIOMEDICAL INC.·D767C0515010·Ti-Enforced® ePTFE membranes are a multi-layer,...

    Phonak Brand

    FDA UDI
    Sonova AG·07613389499162·Phonak Brio 5 I-312

    Medline

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10884389027998·FENESTRATED DRAPE, 24 X 30

    ENDOPOUCH RETRIEVER

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

    V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0515010·CR Tibial Insert, UHMWPE + Vitamin E, Size 5, ...

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·January 28, 2026

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·April 10, 2013

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DWF·April 4, 2011

    ETS FLEX45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDW·May 12, 2008

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·August 18, 2025

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 26, 2026

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 29, 2026

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022