BEUDAMED
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    LiDCOunity Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304242890·

    INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 10, 2015

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 30, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 17, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 1, 2013

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 8, 2014

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM 1.2X6MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·June 17, 2011

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    CRIT-LINE BLOOD CHAMBER

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KOC·July 21, 2018

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012