BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO PRISMALIX SURGICAL LIGHT

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

    Leksell Vantage Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201501269·FirmFix™ 1

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989024784·BONDABLE LINGUAL RETAINER CUSPID 5

    n/a

    FDA UDI
    Ortho Development Corporation·00822409073801·10/12 Distal Reamer 15mm

    20GA Curved Laser Probe, SMA906

    FDA UDI
    Peregrine Surgical, Llc·00632307001796·20GA Curved Laser Probe, SMA906

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126314·CO2 NASAL CANNULA W/O2, INFANT

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310400150·Talar Osteotmy Guide, 40mm x 15mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710820400150·Zadik Calcaneal Guide, 40mm x 15°

    BARCOMED 2MP2

    FDA 510(k)
    FDA Class 2 ·Radiology

    BEAM BLOCK TRAYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 8, 2013

    U BY KOTEX CLICK TAMPONS

    FDA Adverse Event
    Malfunction ·AVENT SA DE R.L. DE C.V.·Product code HEB·March 9, 2011

    MBT CEM KEEL TIB TRAY SZ4

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·May 6, 2008

    HIP END EFFECTOR, VARIABLE ANGLE

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 8, 2016

    HIP END EFFECTOR, VARIABLE ANGLE

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 5, 2016

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·June 18, 2019

    Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·June 24, 2015

    Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·January 9, 2013

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024