BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads

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

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003531·MCK FEMORAL TRIAL (SIZE 8 LM/RL)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018704·CALIBRA 1ST MOLAR BANDS n.LL 8

    BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR

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

    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMPLATZER CRIBRIFORM OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·October 12, 2018

    STAR TOTAL ANKLE REPLACEMENT

    FDA Adverse Event
    Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·October 9, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 21, 2011

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 23, 2015

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 18, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·June 17, 2019

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·January 23, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 16, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·October 8, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 17, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 11, 2019

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022