BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

    FDA 510(k)
    FDA Class 2 ·Hematology

    AtoN Keywest Headlight without Fiber Optic Cable

    FDA UDI
    LONG ISLAND TECH·00851610007091·Light, Surgical, Endoscopic, Accessory

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496003267·NAOMI 30, SIZE XL, CHAMPAGNE, GRADUATED COMPRES...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085024110·QC1 Malaria Slide

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003147·Jacobson Micro Needle Holder Flat Knurled Handle

    HARDY DISK CEFTIZOXIME, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GE SYSTEM FIVE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 6, 2025

    BIO-CORKSCREW SUTURE ANCHOR

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

    OT VERIO IQ METER

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 28, 2011

    GUT SURGICAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAL·February 27, 2008

    UNKNOWN CAGE/SPACER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code OVD·June 11, 2021

    UNKNOWN CAGE/SPACER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code OVD·June 11, 2021

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    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