BEUDAMED
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    Oxylight

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

    Tether

    FDA UDI
    Seaspine Orthopedics Corporation·10889981101626·Var. Angle Center Guide

    Drill Guide

    FDA UDI
    Treace Medical Concepts, Inc.·00810111221733·Contour Drill Guide

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034364·1.6mm Calibrated Drill Bit, D-Latch

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR32001041·Inner screw 1,5 mm f. mand. protrusion appliance

    DEBAKEY TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896059825·DEBAKEY TISSUE FORCEPS FLAT HANDLE

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869608213·TELIX K Pusher

    HYBERNITE RAINOUT CONTROL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Abutment Design

    FDA 510(k)
    FDA Class 2 ·Dental

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 9, 2024

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 25, 2016

    HIGH DEFINITION LCD MONITOR

    FDA Adverse Event
    Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·December 26, 2022

    MANUAL FILL INFANT HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 15, 2008

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 10, 2011

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·July 1, 2013

    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    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