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

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    Rubicon SA System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CALIPER CASTROVIEJO 40MM CRV LONG

    FDA UDI
    W.H. Holden, Inc.·D9282006540·

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457233725·Tri-lobe

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964094613·Endo Carry-On Procedure Kit

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120065400000·Left Offset Compressor Tip

    STRATASIS SLING KIT

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

    VBMAX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OBTURATOR FOR VENFLON/SAFELON1.0X32

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 22, 2020

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·October 16, 2008

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021