BEUDAMED
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    THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

    FDA 510(k)
    FDA Class 2 ·Immunology

    Provena Midline

    FDA UDI
    Bard Access Systems, Inc.·00801741188763·Catheter Placement Kit

    FALOPE-RING

    FDA UDI
    Gyrus ACMI, LLC·00821925028869·FALOPE-RING BAND GUIDE KIT W/ 1-Band Guide, 2-B...

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522111174·LWS ADAPTER, 5 LEAD, SL

    NUZONE NITRILE SURGICAL GLOVES POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 24, 2011

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·February 21, 2008

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 15, 2015

    Minor/General/Ortho Pack, part number PSS3258(B

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·June 24, 2015

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025