BEUDAMED
    82 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    REGARD Newborn Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    REGARD Vitrectomy Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    REGARD Stereotactic Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    REGARD Ear Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    REGARD Ultrasound Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    REGARD Basic Cataract tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    REGARD Core Biopsy Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 24, 2021

    Isolation Droplet Bundle Kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 8, 2020

    Regard, Item Number 830067009, custom cardiovascular procedure kit

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·April 14, 2021

    Respirator Crash Cart Kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 8, 2020

    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·February 5, 2020

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·September 25, 2024

    Regard Kit containing the Microtek decanter

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·August 28, 2024

    Regard Dressing Change Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·May 19, 2021

    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·March 9, 2022

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·June 15, 2022

    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 6, 2022