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

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    UNICONDYLAR INTERPOSITIONAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Defendo Single Use Valve Kit

    FDA UDI
    MEDIVATORS INC.·00724995246853·DEFENDO Air Water, Suction and Cleaning Adapter...

    Defendo Single Use Valve Kit

    FDA UDI
    MEDIVATORS INC.·40677964024366·DEFENDO Air Water, Suction and Cleaning Adapter...

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099815·MX 1-2 BI BD KT N/L UNIV 131

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023687·QC1 AFB Positive Slide

    DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC

    FDA 510(k)
    FDA Class 2 ·Dental

    BELLEGLASS HP OPACEOUS DENTIN

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 8, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 18, 2024

    Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RAD-8

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·February 4, 2016

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    6461500 INFUSOR PUMP (1 LABEL)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

    3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HRS·February 27, 2008

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 20, 2018

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·April 23, 2018

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016