BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    PRIMED Surgical Masks and PRIMED Procedure Masks

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

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000856786·IMPLANT 6240286 ANATOMIC 18X16X12MM

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994304995·IMPLANT 6240286 ANATOMIC 18X16X12MM

    ANATOMIC PEEK CERVICAL FUSION SYSTEM

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994360472·IMPLANT 4240286 ANATOMIC C 18X16X 12MM

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...

    ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(H)

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·August 12, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    OT ULTRA2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·June 11, 2019

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    3.2MM DIAMOND MATCHSTICK, EXTENDS 28.5MM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021