BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    Dentca Base Premium, Dentca Base Hi-Impact

    FDA 510(k)
    FDA Class 2 ·Dental

    Suture Shuttle Right - Green

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215164904·

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127029455·Bipolar Head Assembly, Size 42mm

    TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYCARE LATEX EXAMINATION GLOVE, POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INNATE IMPLANT 3.6MM X 55MM

    FDA Adverse Event
    Injury ·EXSOMED CORPORATION·Product code HWC·September 15, 2023

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 12, 2011

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·August 6, 2014

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    EasyPoint Needle, 25G x 5/8", REF: 82091

    FDA Enforcement
    Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Enforcement
    Class II ·Ongoing·Theken Companies LLC·October 29, 2025

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Recall
    Open, Classified ·Theken Companies LLC·Product code MEH·September 11, 2025

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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