229 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.
FDA Recall
Terminated
·CaridianBCT, Inc.·Product code KZE·June 1, 2010
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·June 16, 2021
Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse
FDA Recall
Terminated
·Capitol Vial Inc·Product code JKA·October 7, 2011
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JDI·May 7, 2021
GENICON EZEE Retrieval, sterile, Rx only.
FDA Recall
Terminated
·Genicon, Inc.·Product code GCJ·July 19, 2017
GENICON EZEE Retrieval, sterile, Rx only.
FDA Enforcement
Class II
·Terminated·Genicon, Inc.·March 28, 2018
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
FDA Recall
Terminated
·Sorenson Medical, Inc.·Product code BSY·November 25, 2002
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·August 13, 2021
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 6, 2021
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·August 12, 2011
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·March 21, 2018
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·December 30, 2015
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·August 29, 2017
NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code OAB·January 20, 2012
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
FDA Recall
Terminated
·CMP Industries, Llc·Product code EBI·April 28, 2016