BEUDAMED
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    SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131262349·H10, RITE 312 WL STG

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046214·Small Medium, DreamWear Full Face Mask, Medium ...

    SAFIRE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TI MATRIX LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·May 29, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 15, 2011

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 22, 2008

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 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

    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