BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX

    FDA 510(k)
    FDA Class 2 ·Dental

    PLAYTEX BREAST PUMP

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

    ONE DIMENSIONAL WATER PHANTOM, WP 1D

    FDA 510(k)
    FDA Class 2 ·Radiology

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·February 24, 2021

    LUMENIS ONE

    FDA Adverse Event
    Malfunction ·LUMENIS, LTD.·Product code GEX·May 3, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·September 8, 2014

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Injury ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·May 9, 2011

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·November 6, 2023

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024