BEUDAMED
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    Genesys Spine Apache Cervical Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGXO

    FDA UDI
    Oticon A/S·05707131281548·H150V2, BTE 13 WL 85 TC AGXO

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321508120·

    TALOS®-A

    FDA UDI
    SpineArt SA·07640375237880·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D28 ...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311508120·

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 14, 2019

    90XL INSTRUMENTATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTICARE DISPOSABLE PEN NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPTURED HIP SCREW LAG SCREW

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·June 6, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 21, 2011

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018