BEUDAMED
    48 results · 13ms · Sources: EU EUDAMED, US FDA

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    CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan Dx Pre-PCR (-20C) MOD T E W, CytoScan Dx Pre-PCR (2-8C) MOD F L H, CytoScan Dx Post-PCR (-20C) MOD S AH W PB, CytoScan Dx Post-PCR (2-8C) MOD E PW, CytoScan Dx Post-PCR (15- 30 C) CytoScan Dx WS A CytoScan Dx WS B CytoScan Dx Array kit, 6Pk ChAS Dx Analysis Software and Browser

    FDA Recall
    Terminated ·Affymetrix Inc·Product code PFX·April 14, 2016

    Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

    FDA Enforcement
    Class II ·Terminated·Vascular Solutions, Inc.·June 27, 2018

    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·March 7, 2018

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·August 27, 2014

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·August 27, 2014

    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·August 27, 2014

    Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LJS·September 15, 2005

    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

    ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code FJS·October 20, 2014

    Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175

    FDA Enforcement
    Class I ·Terminated·Applied Medical Resources Corp·May 13, 2020

    Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·June 3, 2020

    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014