BEUDAMED
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    ACEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506087219·GROOVED DIRECTOR, 13CM (5-1/8")

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193109077·HA PEEK EVOS Straight, ,13mmx11mmx 30mm , FLAT ...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0110130·Sounder, Ball Tip, Straight, Soft, Titanium

    MODIFICATION TO SCINTRON IV

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL

    FDA 510(k)
    FDA Class 2 ·Dental

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 14, 2013

    COBRA REVOLUTION BIPOLAR CLAMP

    FDA Adverse Event
    Malfunction ·ENDOSCOPIC TECHNOLOGIES, INC., DBA ESTECH·Product code GEI·April 20, 2011

    ADVANTA

    FDA Adverse Event
    Injury ·HILL-ROM RITTER·Product code FNL·August 12, 2008

    BD ® QUINCKE NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON, S.A.·Product code FMI·June 28, 2023

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024