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

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    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·CDS II (SODIUM CHONDROITIN SULFATE)

    Catheter, Balloon For Retinal Reattachment

    FDA Pre-Market Approval
    FDA Class 3 ·LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER

    AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·LIFESPAN(TM) 100 TCPCO2 MONITOR

    Catheter, Balloon For Retinal Reattachment

    FDA Pre-Market Approval
    FDA Class 3 ·LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER

    Catheter, Balloon For Retinal Reattachment

    FDA Pre-Market Approval
    FDA Class 3 ·LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·LIFESPAN(TM) 100 TCPCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·LIFESPAN(TM) 100 TCPCO2 MONITOR

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE

    Monitor, Carbon-Dioxide, Cutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·LIFESPAN(TM) 100 TCPCO2 MONITOR

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·June 6, 2025

    DURALENS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·May 4, 2016

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2012

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVY·June 4, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021