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

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    Biosteon® Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Powder Free Nitrile Patient Examination Gloves, Blue Color

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DYNATRON DX2 TRACTION UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·November 14, 2014

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·August 31, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 2, 2023

    Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

    FDA Enforcement
    Class II ·Ongoing·Clinical Innovations, LLC·May 6, 2026

    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

    FDA Enforcement
    Class III ·Terminated·Biomet, Inc.·June 17, 2015

    BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024