BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    MENIX®; MENIX® DUO

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705022922·ORTHOCORD Violet Braided Composite Suture SH 26...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113899·VISCO INJECTION CANNULA 26GA

    APEX 6

    FDA 510(k)
    FDA Class 2 ·Neurology

    GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 4, 2014

    XIENCE V

    FDA Adverse Event
    Death ·ABBOTT VASCULAR·Product code NIQ·August 16, 2011

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 12, 2013

    Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM 00630414949819; Dimension¿ Xpand¿ Plus 00630414949833; Dimension¿ Xpand¿ Plus HM 00630414949840; Dimension¿ RxL Max Refurbished 00630414592947; Dimension¿ RxL Max HM Refurbished 00630414592954; Dimension¿ Xpand¿ Plus Refurbished 00630414592961; Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978; Dimension¿ EXL with LM Refurbished 00630414000268; Dimension¿ 200 Refurbished 00630414010717;; Dimension¿ RxL Max w/o HM International 00630414949802; Dimension¿ RxL Max HM International 00630414945477; Dimension¿ RxL Max HM STM International 00630414949826; Dimension¿ Xpand Plus w/o HM International 00630414949857; Dimension¿ Xpand Plus w/HM International 00630414945484; Dimension¿ EXL with LM International 00842768030024; Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609 The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 14, 2018

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023