BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    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

    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

    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

    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

    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

    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

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

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

    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

    Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 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

    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

    FDA Enforcement
    Class II ·Terminated·TeDan Surgical Innovations LLC·May 13, 2020

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    FDA Enforcement
    Class II ·Terminated·Access Scientific LLC·May 20, 2020

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    FDA Enforcement
    Class II ·Terminated·Access Scientific LLC·May 20, 2020

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    FDA Enforcement
    Class II ·Terminated·Access Scientific LLC·May 20, 2020

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    FDA Enforcement
    Class II ·Terminated·Access Scientific LLC·May 20, 2020