BEUDAMED
    21 results · 30ms · Sources: EU EUDAMED, US FDA

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    DORO QR3 Headrest System (Aluminum)

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486021641·HIP OFFSET CUP IMPACTOR (TJO)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM

    18M - Loggers - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

    Drive Rail

    FDA UDI
    ORTHOPEDIATRICS CORP.·00817867020306·Hinge, Low Overhang +5mm

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756105699·CAST BOOT

    KFA-127 KNEE, FOOT AND ANKLE ARRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    VBL SERUM TROPONIN I TEST, MODEL 1001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376520636·16 mm CORE ENDPLATE, LAT 20 x 35 mm 5°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376519500·12 mm CORE ENDPLATE, LAT 20 x 35 mm 5°

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code MHY·October 17, 2008

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·August 11, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code LKK·July 2, 2013

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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