BEUDAMED
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    JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481119439·LOCATOR F-Tx Abutment For Small Internal Conica...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481112973·LOCATOR R-Tx Abutment for Small Internal Conica...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129308·LOCATOR R-Tx Abutment, Astra TX Connection (Aqu...

    VADER Pedicle System, Rod, Carbon/PEEK, J-Rod, Ø 6.0 r000 + r450 x 60/50 mm

    FDA UDI
    icotec AG·07640164847023·VADER Pedicle System, Rod, Carbon/PEEK, J-Rod, ...

    ATLAST DATA MANAGEMENT SOFTWARE (DMS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STACKHOUSE LENS HOOD, MODEL SA-700/F

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

    PRECICE PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code KTT·June 8, 2021

    11.0MM TI HELICAL BLADE 95MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code HSB·April 22, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·April 14, 2011

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 1, 2008

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC DOMINICANA·Product code EQJ·September 5, 2024

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC DOMINICANA·Product code EQJ·September 5, 2024

    XPS® BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·September 11, 2025

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC DOMINICANA·Product code EQJ·September 5, 2024

    COLIBRI II HANDPIECE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·December 3, 2024

    DiaSorin Analyte Specific Reagent

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DGK·January 18, 2005

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

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

    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 17, 2014