BEUDAMED
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    NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964005341·The ENDO CARRY-ON Procedure Kit contains all of...

    Nobel

    FDA UDI
    Preat Corporation·00842092101346·NobelBiocare™ Tri-Lobe-compatible WP (5.0mm) Cl...

    Tooth Tone

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730014818·NiTi Coated Upper 020 10 archwires per pack

    PediFlex

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132133446·PEDIFLEX STAINLESS STEEL IMPLANTS & ACCESSORY S...

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·June 16, 2024

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WIN-1 TANGO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2026

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·March 12, 2013

    TRIAGE PROFILER SOB 25 TEST KIT

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code NBC·February 2, 2011

    9600+

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 21, 2008

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·July 6, 2017

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2020

    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

    FDA Recall
    Terminated ·Product code FTR·September 12, 2003

    BrightView SPECT (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

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·November 4, 2015

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024