BEUDAMED
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    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...

    SIMPLELINE II ABUTMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000034641·PROSTHESIS 1112045 H/A TOTAL 90 RECT

    CoverLoc

    FDA UDI
    TORNIER, INC.·00846832001309·K-WIRE

    NA

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490033299·PROSTHESIS 1112045 H/A TOTAL 90 RECT

    Lateral Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837089597·

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521112045D0·12 x 45 mm Anodized SI Implant Fully Threaded

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981319878·Mariner MIS-TAP, Ø4.5mm, 40mm Thread

    DIMENSION VISA HBA1C, MODEL K3105A

    FDA 510(k)
    FDA Class 2 ·Hematology

    HIGHGATE CURVED ROD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENCOR FIRE FORWARD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·November 24, 2022

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code FZP·April 6, 2023

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021