BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ETI-AB-EBK PLUS

    FDA UDI
    DIASORIN SPA·08056771102346·

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328662·TEMPLATE 3001929 ZEVO 29MM 1 LVL

    SCANLAN® Easy-Tag™ Tracking System

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033014·Easy-Tag Pre-Printed, Tray Incomplete/Missing, ...

    PROLITE PULSED LIGHT SYSTEM

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

    GEIGER NEEDLE ADAPTER, MODEL 406

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

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 30, 2026

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 29, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 29, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 29, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 29, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 29, 2024

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 11, 2013

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·February 27, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·February 15, 2008

    SCREWDRIVER BLADE, CANNULATED

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·November 27, 2018

    DRILL AND SCREW GUIDE

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code LXH·February 10, 2016

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024