BEUDAMED
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    VariAx 2 One-Third Tubular Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

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

    XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 6, 2011

    7" SMALLBORE EXT. SET W/REMV. MICROCLAVE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·May 20, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·June 7, 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

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

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