BEUDAMED
    205 results · 18ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Ongoing·ARROW INTERNATIONAL, LLC·April 29, 2026

    prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5

    FDA Enforcement
    Class II ·Ongoing·Centinel Spine, Inc.·October 2, 2024

    Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 26, 2020

    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 21, 2018

    prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5

    FDA Enforcement
    Class II ·Ongoing·Centinel Spine, Inc.·October 2, 2024

    Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 26, 2020

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 26, 2019

    ArrowClarke" PleuraSeal¿ Thoracentesis Kit

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 11, 2018

    Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 28, 2018