BEUDAMED
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    GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    KEY SURGICAL, INC.·00849771052289·K-Wire and Steinmann Pin Dispensers, No Dispen...

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122155·KWire .028x4" (0.7x100mm)

    Bone Screws

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132134399·ZIMMER TRI-SHANK QUICK CONNECT END

    Prosthesis Head Large

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575993291·Prosthesis Head,

    MICROSTREAM ORAL NASAL CANNULA FILTERLINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CALCIJECT

    FDA 510(k)
    FDA Class 2 ·Dental

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code HES·December 5, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 23, 2026

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·April 22, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·April 27, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025