BEUDAMED
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    URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099815·MX 1-2 BI BD KT N/L UNIV 131

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019100·Castroviejo Needle Holder Flat Handle

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2024

    INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOSE 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·KESTRA MEDICAL TECHNOLOGIES, INC.·Product code MVK·December 30, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    STAR TOTAL ANKLE REPLACEMENT

    FDA Adverse Event
    Injury ·WALDEMAR LINK, GMBH & CO.·Product code NTG·February 16, 2011

    BOSTON SCIENTIFIC

    FDA Adverse Event
    Malfunction ·NAMIC/VA·Product code DXT·February 25, 2008

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·November 13, 2023

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024