BEUDAMED
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    ALERE BINAXNOW INFLUENZA A & B CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HHM

    FDA UDI
    Oticon A/S·05707131262288·H100, RITE 312 WL SGR HHM

    DreamWear Full

    FDA UDI
    Respironics California, Inc.·00606959045965·M, DreamWear Full, Sm Frm WO HGR, GBL

    Brasseler USA

    FDA UDI
    Provision·B504OMKM334110·

    Brasseler USA

    FDA UDI
    Provision·00810041064967·

    NA

    FDA UDI
    STERILMED, INC.·10888551017138·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...

    IDEAL IQ SOFTWARE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    PFC SIGMA C/S NPOR FEM LT SZ 3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 13, 2011

    ELECSYS 2010 DISK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·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