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

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    RIESS-LUHR

    FDA 510(k)
    FDA Class 1 ·Dental

    ERA® RV Males (2 blk, 2 wht, 1 org).

    FDA UDI
    STERNGOLD DENTAL LLC·00841549101007·Package contains 2-each Black & White ERA males...

    Couture Essence

    FDA UDI
    Carolon Company·00078301871131·

    Couture Essence

    FDA UDI
    Carolon Company·00078301811137·

    BoneCam

    FDA UDI
    MEDLINE INDUSTRIES, INC.·00818614020921·

    CoLink™ Afx Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 24, 2014

    REVEAL DX

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DSI·October 31, 2012

    OVER THE MATTRESS SENSOR PAD

    FDA Adverse Event
    Malfunction ·POSEY MEDICAL DEVICE LTD.·Product code KMI·August 13, 2010

    Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015