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

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    URETERAL BALLOON DILATATION CATHETER

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

    SureLOK MIS 3L

    FDA UDI
    PRECISION SPINE, INC.·00840019920193·MIS 3L Serial Dilator, 13mm

    SureLOK Pedicle Screw System

    FDA UDI
    PRECISION SPINE, INC.·00815362021804·SureLOK MIS Radel Dilation Tube 13mm

    SOPRO 281

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

    OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 11, 2022

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 4, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 20, 2010

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015