BEUDAMED
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    Materialise PKA Guide System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814701·GENUMEDI SILVER SIZE VII

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM

    24M - Salt River Project-21 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal

    36M - Salt River Project-31 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588022024·36M - Salt River Project-31 - Metal

    AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MACROPOREPX PEDIATRIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 16, 2008

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code NVZ·June 28, 2013

    Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·June 23, 2021

    Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·June 23, 2021

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Enforcement
    Class II ·Terminated·DRG International, Inc.·April 13, 2022

    Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020

    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·April 25, 2018

    Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020

    Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020

    Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·April 6, 2022

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Enforcement
    Class III ·Ongoing·Alcon Research LLC·November 27, 2024

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 12, 2022