BEUDAMED
    16 results · 37ms · Sources: EU EUDAMED, US FDA

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    Scooter (Model: FDB01)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    2.0MM SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036033743·

    LIPOSUCTION CANNULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0992011960·LIPOSUCTION CANNULA 1X2 TOTEM STYLE

    JEL BIOS 90 (CODE NAME RD-2401)

    FDA 510(k)
    FDA Class 2 ·Dental

    NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735

    FDA 510(k)
    FDA Class 2 ·Neurology

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 28, 2018

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2023

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·October 27, 2014

    CARESCAPE MONITOR B850

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·July 29, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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