BEUDAMED
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    TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741226350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674122635060·

    APOLONIA LASER IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    KUSKE BREAST APPLICATOR SET, MODEL 189.006

    FDA 510(k)
    FDA Class 2 ·Radiology

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC·Product code LIT·March 29, 2016

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 21, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014

    DURALOC CONST LINER 52X32

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 3, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 26, 2015

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024