BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827875·***DISC*LEVAMED ANKLE SUPPORT BLACK V

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482038710·Symmetry® Probe, Double-Ended, Stainless Steel,...

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962108741·PROBE, 6", DOUBLE ENDED, SS

    MODIFICATION TO SYNERGY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 20, 2021

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·November 24, 2010

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 10, 2014

    BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·May 2, 2013

    CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 15, 2014

    KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA

    FDA Adverse Event
    Malfunction ·WELCH ALLYN, INC.·Product code HIB·April 20, 2011

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024