BEUDAMED
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    Cryotop US

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014812·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 27

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM

    Endo-Model Standard Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575030996·Rotational Knee Replacement Set

    Endo-Model Standard Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575031009·Rotational Knee Replacement Set

    Endo-Model Standard Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575026555·Rotational Knee Replacement Set

    Endo-Model Standard Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575030095·Rotational Knee Replacement Set

    VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECTROTORQUE TLC

    FDA 510(k)
    FDA Class 1 ·Dental

    3006721341-2019-00009

    FDA Adverse Event
    Injury ·March 22, 2019

    SONICFILL COMPOSITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·October 8, 2014

    VISIONAIRE

    FDA Adverse Event
    Death ·AIRSEP CORP.·Product code CAW·June 28, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

    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

    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