BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    SURGITRON IEC II

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

    Preat

    FDA UDI
    Preat Corporation·00842092182581·ASC Straumann Tissue Level RN/WN-Compatible Tit...

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126531·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001253·artVeneer life lower anteriors, UCS, B3

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370012530·Health-Tec/DHP Excavator DE 38/39

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 26, 2026

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 26, 2026

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 26, 2026

    SYRINGE 50ML LL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 18, 2020

    SILENT NIGHT V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 24, 2011

    AMX 4 PLUS

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code IZL·February 22, 2008

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 3, 2020

    L3W0750 - DUODERM

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·February 28, 2021

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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