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

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    INTERACTIVE REAL TIME SCANNING PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    KALORE™

    FDA UDI
    Gc America Inc.·14548161291385·KALORE™ Unitip 20 Tips (0.16mL each)

    KALORE™

    FDA UDI
    Gc America Inc.·D0470036231·KALORE™ Unitip 20 Tips (0.16mL each)

    L10-3s Ultrasonic Probe(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088488·

    SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

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

    SCULPTURE FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    IABP (INTRA AORTIC BALLOON PUMP) UNKNOWN

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·August 29, 2025

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    2520274-2013-11003

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·February 28, 2013

    FALOPE-RING BAND TWO-RING APPLICATOR

    FDA Adverse Event
    Injury ·GYRUS MEDICAL, INC.·Product code KNH·February 23, 2011

    ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE-12MM DIAMETER,100MM SLEE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GCJ·February 15, 2008

    HAND PIECE FOR BATTERY

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·March 28, 2014

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

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

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