BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HAL for Medical Use(Lower Limb type)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EarQ

    FDA UDI
    Oticon A/S·05707131352385·G50 S, MINIRITE 312 2.4G C093 EARQ

    FAC-4 - Duke Power Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450273401·

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025

    CALCIUM SULFATE PELLETS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCENT ALL-POLY PS TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WALLFLEX DUODENAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

    LUMAX 340 DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code LWS·October 16, 2008

    HUDSON AQUAPAK W/ADAPTOR, INTL.

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code CAF·August 3, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    WALLFLEX COLONIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024

    WALLFLEX COLONIC

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·April 5, 2017

    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