BEUDAMED
    46 results · 12ms · Sources: EU EUDAMED, US FDA

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    Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·April 4, 2006

    Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·July 17, 2006

    MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·August 6, 2004

    Dynesys L.I.S. Stabilizing cord Rx, Sterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code NPQ·September 4, 2012

    MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·May 14, 2007

    Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001. For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NPQ·March 31, 2011

    MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·November 5, 2004

    Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690 (Return). An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·July 17, 2006

    NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery

    FDA Recall
    Terminated ·Synthes Spine·Product code NPQ·November 7, 2008

    Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection of genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NPQ·October 26, 2010

    Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·April 4, 2006

    Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·April 4, 2006

    Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NPQ·July 17, 2006

    NFlex Stabilization System 200 mm, Catalog number NF60020-1. spinal fusion surgery

    FDA Recall
    Terminated ·Synthes Spine·Product code NPQ·November 7, 2008

    Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEM·June 10, 2019

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022