BEUDAMED
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    VECTRA NEO CLINICAL THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565266·CoRoent Ant TLIF PEEK, 13x12x28mm 4°

    Oticon

    FDA UDI
    Oticon A/S·05707131257871·H16, MINIBTE 312 WL 85 SGR

    XIVE TG DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    KRYSTALRAD 560 (FLAATZ 560)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 19, 2023

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 9, 2020

    M2A-MAGNUM MODULAR HEAD SZ 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 29, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2011

    PULMONETIC

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 203 /PULMONETIC SYSTEMS, INC.·Product code CBK·August 22, 2008

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER 22GA 1.00IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 17, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code HBC·March 26, 2018

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    FDA Enforcement
    Class II ·Terminated·Neurotherm, Inc.·April 20, 2016

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015