BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    HI-TORQUE PROGRESS GUIDE WIRE FAMILY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989026887·ARCH P/F EDG.RECT.LO180 X250 PK10

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450309070·

    STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE

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

    PANORAMA CENTRAL STATION W/ TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 17, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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