64 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKO·May 7, 2021
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKO·May 7, 2021
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·June 30, 2021
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·June 30, 2021
Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part Number: A54378, UniCel DxC 600i APF, Part Number: A54379, UniCel DxC 600i AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·September 11, 2008
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·September 11, 2008
Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland
FDA Recall
Terminated
·Boston Scientific Corporation One Boston·Product code DQO·October 12, 2007
Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code LJS·September 15, 2005
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
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
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code DQR·October 14, 2020
Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress)
FDA Recall
Terminated
·AMF Support Surfaces Inc·Product code DWJ·January 27, 2005
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
FDA Enforcement
Class II
·Terminated·AAP Implantate Ag·March 27, 2019
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
FDA Enforcement
Class III
·Terminated·AAP Implantate Ag·January 1, 2020
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
FDA Enforcement
Class III
·Terminated·AAP Implantate Ag·January 1, 2020
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
FDA Enforcement
Class II
·Terminated·AAP Implantate Ag·April 15, 2020
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories, Inc.·February 19, 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 Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·November 22, 2013
Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc., Hercules, CA
4000 Alfred Nobel Dr
Hercules CA 94547-1803·Product code LCP·September 8, 2010