BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    INSTRUMED RETRACTORS

    FDA 510(k)
    FDA Class 2 ·Neurology

    RANDOX THEOPHYLLINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SHIMADZU COLLIMATOR R-30H

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PU·Product code EZW·February 1, 2013

    PF4 IGG

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 5, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·April 22, 2013

    COLLAMEND

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTM·April 20, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 7, 2008

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    GII OVAL RESURFACING PAT 32MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024