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    LEKSELL GAMMAPLAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    NexxZr™ / W-98-18-UT-B400-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139115·

    RUSKIN-LISTON BONE CUTTING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896051386·RUSKIN-LISTON BONE CUTTING FORCEPS DOUBLE ACTIO...

    ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROGAV®

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·April 12, 2012

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO VILLALBA·Product code DTB·April 9, 2026

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LGD·May 25, 2011

    SELECTSECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·December 17, 2024

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025