BEUDAMED
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    PICOSURE WORKSTATION

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574831·CoRoent Ant TLIF Ti, 13x13x36mm 4°

    HHM

    FDA UDI
    Oticon A/S·05707131260673·H110, MINIRITE 312 WL SIL HHM

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

    CHAD THERAPEUTICS SAGE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2016

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·May 29, 2013

    MICROSENSOR VENTRICULAR CATHETER KIT

    FDA Adverse Event
    Death ·CODMAN & SHURTLEFF, INC.·Product code GWM·June 16, 2011

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 22, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015