BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Graves Vu-Max X Long

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030979·Graves Vu-Max X Long 6 3/4" (171mm)

    REDI-SCREEN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    S4C POLYAXIAL SCREW 3.5X12MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009

    ULTRAPRO MESH

    FDA Adverse Event
    Injury ·ETHICON, INC·Product code FTL·April 2, 2013

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 4, 2011

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GDO·July 16, 2014

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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