BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    ONCE-A-DAY VERTOS TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180826200·

    Centaur Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215126957·

    SE-200

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

    SURESMILE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 12, 2026

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 23, 2013

    CHOLESTECH LDX ANALYZER

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code CHH·April 27, 2011

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 23, 2008

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·May 9, 2014

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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