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

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    ELECSYS INSULIN CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964015784·Endo Carry-On Procedure Kit

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100

    TensCare

    FDA UDI
    TENSCARE LIMITED·05033435136490·The Nouri Digital Electric Breast Pump is a pow...

    BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TKD SCALERS

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDTRONIC EXTENDED INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 16, 2024

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 13, 2013

    SHUNT SENSOR SYS500

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 3, 2011

    ACHIEVA

    FDA Adverse Event
    Malfunction ·GALWAY (RC)·Product code CBK·February 25, 2008

    ENVEO R DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 19, 2021

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 19, 2021

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 19, 2021

    ENVEO R DELIVERY SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 19, 2021

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020