BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH

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

    LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RF-IVD WIRELESS DOSIMETER-MODEL 1133

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 5, 2022

    HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code CCQ·June 26, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 5, 2013

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 23, 2011

    INDURA

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·April 18, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021