BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·AQUA SOFT CONTACT LENS

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·AQUA-SOFT (DELTAFILC

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·TRI POL

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496018162·MARILYN 140 SHEER, SIZE M, MOKA, GRADUATED COMP...

    BMT Medizintechnik GmbH

    FDA UDI
    BMT Medizintechnik GmbH·04251725201647·PERIO. SURG. SANDERS, #1/2

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471070745·SAGITTAL BLADE - HALL (5023-162) 5.5 x 18.5 x 0...

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862273789·

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·July 14, 2004

    BOWA RETURN ELECTRODE

    FDA Adverse Event
    Injury ·BOWA-ELECTRONIC GMBH & CO. KG·Product code GEI·July 26, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 15, 2025

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 18, 2021

    TWIST MP-1, 3.75, 13MM

    FDA Adverse Event
    Injury ·SULZER CALCITEK·Product code DZE·April 12, 1999

    MEDISENSE COMPANION 2 METER

    FDA Adverse Event
    Malfunction ·MEDISENSE, INC.·Product code CFR·September 3, 1997

    PROXIMATE LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·February 27, 2001

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014