BEUDAMED
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    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112953·CORNEAL TREPHINE BLADE8.5MM

    Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    SprintRay Apex Teeth - Bleach - 500 g

    FDA UDI
    Sprintray, Inc.·00850039704727·APEX Teeth is a light-curable polymerizable res...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM

    BALLISTA INSTRUMENTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code LXH·February 8, 2011

    STRETCH VINYL EXAMINATION GLOVE POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    XIA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 7, 2016

    GE OEC 8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008

    CAPSURE SP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 28, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    MAGNETOM Vida Fit. Model Number: 11410481.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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