BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Dermapose Refresh

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

    Contrast Line

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207473·Contrast Line 20"(50cm) Female/Rotating Adapter...

    COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEUS ELISA HSV GC-I IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008

    GRIPPER PLUS

    FDA Adverse Event
    Malfunction ·DELTEC, SMITH MEDICAL ASD, INC·Product code FMI·June 20, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·July 29, 2011

    PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024