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

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    ENDOSSEOUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD SAFETY-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·August 21, 2024

    BD PLASTIPAK¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 30, 2023

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 27, 2011

    AMPLATZ UROLOGICAL GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code EZB·July 23, 2008

    TRIAL SPACER HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTD·July 9, 2015

    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