BEUDAMED
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    PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

    FDA 510(k)
    FDA Class 2 ·Radiology

    NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 22x18x3

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677015729·The NYOrtho APEX CORE Gel-Foam Cushion combines...

    NYOrtho APEX CORE Coccyx Wheelchair Cushion Gel-Foam 22x18x3

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677018720·Designed to remove pressure from the coccyx, th...

    NYOrtho APEX CORE Pommel Wheelchair Cushion Gel-Foam 22x18x3

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677017136·For patients requiring hip positioning, the NYO...

    NYOrtho Wheelchair Cushion Gel-Foam 22x18x3

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677012100·NYOrtho Gel-Foam Cushions combine a dual chambe...

    NYOrtho APEX CORE Coccyx Pommel Wheelchair Cushion Gel-Foam 22x18x3

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677017150·For patients requiring hip positioning and to e...

    REFLECTION CONSTRAINED LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTRAVASCULAR ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 6, 2024

    N/A

    FDA Adverse Event
    Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS·Product code HRX·August 24, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 1, 2008

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·July 5, 2013

    V8 Immunodisplacement Kit REF 1803

    FDA Enforcement
    Class II ·Ongoing·Helena Laboratories, Corp.·June 15, 2022

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 22, 2023

    REFLECTION CONSTRAINED ACETABULAR LINER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025

    V8 Immunodisplacement Kit REF 1803

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code CFF·April 6, 2022