BEUDAMED
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    HAIRMAX LASERCOMB

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70603051·Mini-Mono-Brackets Alexander 'S' .022" 400 Brac...

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707003715·Rumor .018 UL3 0T 11A 4MO

    Klitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707003722·Rumor .018 UL3 HK 0T 11A 4MO

    ROSA Cup Inserter Screw

    FDA UDI
    Orthosoft Inc·00887868518560·

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    WEISS RETINAL CANNULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HARDYDISK, CEFOXITIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CONFIDENCE KIT, NO NEEDLES

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014

    FIBER LIGHT GUIDES

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ANDOVER MANUFACTURING SITE·Product code NBH·January 19, 2012

    SHILEY

    FDA Adverse Event
    Injury ·COVIDIEN / FORMERLY TYCOHEA.·Product code JOH·April 11, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 15, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL LIFECOR CORPORATION·Product code MVK·June 12, 2008

    Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022