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Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .

FDA Recall
Terminated ·Diasorin Inc.·Product code DFC·January 10, 2005

FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

FDA Recall
Terminated ·Fort Defiance Industries, LLC·Product code FLE·May 24, 2018

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

Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.

FDA Recall
Terminated ·Varian Medical Systems Oncology Systems·Product code KPQ·January 3, 2008

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

AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code KPQ·May 24, 2012

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

Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.

FDA Recall
Terminated ·Smith & Nephew Inc·Product code LPQ·June 5, 2009

Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Siemens Medical Solutions USA, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

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

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

Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems

FDA Recall
Terminated ·Varian Medical Systems Inc·Product code KPQ·June 25, 2007

SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·December 11, 2013

Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; Product is manufactured and distributed by Siemens Medical Solutions, Oncology Care System, 4040 Nelson Ave, Concord CA The product is indicated for use in Radiation therapy simulation.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·March 10, 2008

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

Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·October 10, 2014