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

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    N LATEX B2-MICROGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00273121·

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00273011·

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271311·

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 27, 2024

    BD¿ SLIP TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 21, 2017

    MODIFICATION TO RTA RETINAL THICKNESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AVID-NIT LOSS OF RESISTANCE SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XENIUM XPH

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION *USD*·Product code KDI·March 13, 2013

    DELTA CER HEAD 11/13 36MM +3

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code LZO·February 17, 2011

    POLYFLUX S CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code KDI·February 27, 2008

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024