BEUDAMED
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    OrthAlign Plus System

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00142006420·CC-422

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869692847·MOSS Coupler Clamp left

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120064200000·Locking Collar Starter

    SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CO2 Laser System

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

    GREENFIELD VENA CAVA FILTER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DTK·June 9, 2006

    DEEP BRAIN STIMULATION DEVICES

    FDA Adverse Event
    MEDTRONIC NEUROMODULATION·Product code MHY·September 21, 2007

    UNKNOWN PRODUCT INFORMATION

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·July 24, 2006

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 29, 2023

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 24, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021