BEUDAMED
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    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

    FDA Recall
    Open, Classified ·Neotract Inc·Product code PEW·June 24, 2022

    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

    FDA Recall
    Open, Classified ·PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel·Product code QWK·July 16, 2025

    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

    FDA Recall
    Open, Classified ·ENDO Pharmaceuticals Solutions, Inc.·Product code MDM·November 8, 2022

    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

    FDA Recall
    Open, Classified ·Allergan PLC·Product code KYF·October 30, 2019

    USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,

    FDA Recall
    Open, Classified ·United Orthopedic Corporation No.·Product code KRO·January 3, 2024

    USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm

    FDA Recall
    Open, Classified ·United Orthopedic Corporation No.·Product code KRO·January 3, 2024

    USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm

    FDA Recall
    Open, Classified ·United Orthopedic Corporation No.·Product code KRO·January 3, 2024