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

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    Blue Beacon Submucosal Injectable Solution

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

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040187722·ZIRLUX ML DISC B4 98x18

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694005975·1.2mm Screw VISIDISK (YELLOW)

    Insurgical, Inc.

    FDA UDI
    Insurgical, Inc.·00860007230028·Reciprocating Saw Packaged Assembly

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 15, 2014

    VIRIDIS DERMA LASER

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

    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Widex

    FDA UDI
    Widex A/S·05706069370362·Widex mind220 M2-9 BTE (Cappuccino brown ) Tele...

    Widex

    FDA UDI
    Widex A/S·05706069689419·Widex BEYOND B-F2 (Cappuccino brown ) Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069827217·WIDEX EVOKE EBB3D (Cappuccino brown ) Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069424492·Widex MENU ME-9 BTE (Cappuccino brown ) Telecoi...

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 21, 2015

    ECCENTRICAL GLENOSPHERE DIA. 40 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code MBF·December 19, 2022

    VISI-PRO¿ BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code FGE·August 10, 2011

    DELTA VALVE, SMALL, WITH RIGHT ANGLE CONNECTOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·October 15, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

    iCT SP Model # 728311, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015