BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    ACTIVE PSA IRMA (DSL-9700)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Access Myoglobin Calibrators

    FDA UDI
    Beckman Coulter, Inc.·15099590231699·The Access Myoglobin Calibrators are intended t...

    Stainless Steel Femoral Nailing System

    FDA UDI
    ORTHOFIX SRL·18032568862508·STERILE CANN. FEMORAL NAIL DIAMETER 12 MM LENG...

    VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    superDimension Navigation System V7.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244

    FDA 510(k)
    FDA Class 2 ·Immunology

    AVEA COMPREHENSIVE VENTLATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·June 6, 2014

    CANES

    FDA Adverse Event
    PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IPS·February 21, 2013

    CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

    FDA Adverse Event
    Malfunction ·Product code FPA·January 28, 2011

    FIDELITY IAB BALLOON CATHETER

    FDA Adverse Event
    Other ·DATASCOPE CORPORATION·Product code DSP·March 16, 2005

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 19, 2026

    CS300 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·May 10, 2010

    CS100 Intra-Aortic Balloon Pump.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·May 10, 2010

    Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·February 4, 2009

    System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·May 10, 2010

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026