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

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    SERUM PROTEIN SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099860·MN 2ND BI BD KT N/L R/L 176

    PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOGARTY VALVULOTOME, MODEL 700091

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 12, 2013

    PENTA 3MM LEAD, 60 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL -NEUROMODULATION DIV.·Product code LGW·February 23, 2011

    ATLAS20CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (US SURGICAL)·Product code GEI·February 20, 2008

    M2A-MAGNUM (TM) PF CUP 58MM O.D. X 52MM I.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 21, 2016

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·May 19, 2021

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·May 19, 2021

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    2.7X12MM HT X-DRIVE SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·August 4, 2016

    M2A-MAGNUM MODULAR HEAD 52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    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