BEUDAMED
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    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DXF·June 10, 2025

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    FDA Recall
    Open, Classified ·Drs Vascular, Inc·Product code KGS·May 16, 2025

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CFP·October 7, 2024

    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code JLX·September 13, 2024

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code KLI·October 18, 2021

    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDZ·July 5, 2024

    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Recall
    Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

    VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DLJ·April 14, 2023