BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MALDI BIOTYPER CA (MBT-CA) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CIDEX OPA SOLUTION

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON MEDICAL LTD.·Product code MED·November 6, 2008

    MANTIS CANNULATED POLYAXIAL SCREW 7.5 X 55 MM

    FDA Adverse Event
    Injury ·STRYKER SPINE BORDEAUX·Product code MNH·August 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    VAPR CLPLSE90 ELECTRODE W HAND CNTRLS

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code GEI·July 13, 2021

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023

    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.

    FDA Enforcement
    Class II ·Ongoing·Abbott·July 13, 2022

    Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·December 26, 2018

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018