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

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    U-RIGHT COMPRESSOR NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ArgenZ HT+ 98x16 OM1

    FDA UDI
    ARGEN CORPORATION, THE·D818121969·Dental porcelain/ceramic restoration kit

    MH1 MICROHOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHROLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 21, 2013

    HUDSON PEDIATRIC HEATED-WIRE CIRCUIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·May 24, 2011

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 13, 2008

    INSPIRE 8F DUAL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·January 9, 2026

    MEMORY II DOUBLE LUMEN EXTRACTION BASKET

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code LQR·July 28, 2021

    INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024