BEUDAMED
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    Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers in a bulk non-sterile configuration.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·November 30, 2016

    ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

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

    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

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

    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

    FDA Enforcement
    Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·December 4, 2019

    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·May 21, 2014

    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 6, 2017

    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 6, 2017

    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 6, 2017

    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 6, 2017

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems Inc.·February 14, 2018

    Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Wfr/aquaplast Corp·April 6, 2016

    MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

    FDA Enforcement
    Class II ·Terminated·Canadian Hospital Specialties·August 21, 2019

    ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·August 9, 2017

    Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·July 29, 2020

    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. The use of the 4, 5, and 5.5 Fr. antimicrobial surface catheters in infants weighing less than 2.0, 2.5, and 3.0 kilograms respectively, have not been evaluated. Therefore, the benefits of these catheters in infants weighing less than the indicated weights should be weighed against any possible risks.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·August 29, 2018

    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004

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

    Thora-Para 5 Fr Catheter Drainage Tray

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·July 29, 2020

    Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB

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

    5Fr. Catheter Clamp with Fastener; Product Code: CC-00005

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

    5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems Inc.·July 7, 2021