39 results
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20ms
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Sources: EU EUDAMED, US FDA
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
FDA Recall
Terminated
·Stanmore Implants Worldwide Ltd. Centennial Park·Product code KRO·July 4, 2017
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTS·April 14, 2020
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTS·September 29, 2004
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTS·April 12, 2012
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JTS·March 23, 2018
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTS·April 12, 2012
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
FDA Recall
Terminated
·Remel Inc·Product code JTS·October 29, 2014
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTS·April 14, 2020
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTS·April 14, 2020
Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code LNH·April 4, 2018
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
FDA Recall
Terminated
·Deerfield Imaging·Product code LNH·February 10, 2016
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CGA·April 7, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CFR·October 23, 2014
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
FDA Recall
Terminated
·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016
Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
FDA Recall
Terminated
·CTS, Inc. dba Guidant Cardiac Surgery·Product code GCJ·February 5, 2009
VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
FDA Recall
Terminated
·CTS, Inc. dba Guidant Cardiac Surgery·Product code GCJ·September 9, 2008
CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626
FDA Recall
Terminated
·California Medical Laboratories Inc·Product code DTS·January 24, 2008
Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
FDA Recall
Terminated
·Teleflex, Inc.·Product code BTS·November 21, 2014