BEUDAMED
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    NUGEN FX SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERFORMATRAK

    FDA UDI
    Respironics, Inc.·00606959000674·PerformaTrak Mask, Medium, Reusable Pack, Inter...

    AOS CANCELLOUS LOCKING SCREW 4.0mm x 22mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008494·

    Universa

    FDA UDI
    COOK INCORPORATED·00827002532328·Universa, Silicone Foley Catheter Closed End

    EndoVive

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00813939020052·

    SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AERONEB PORTABLE NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·March 21, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

    NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·April 26, 2023

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026