194 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Achilles Express Bone Sonometer
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUA·September 3, 2019
Achilles Insight Bone Sonometer
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUA·September 3, 2019
Achilles Express Bone Sonometer
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 16, 2019
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CEE·April 9, 2015
Achilles Insight Bone Sonometer
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 16, 2019
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
FDA Enforcement
Class II
·Terminated·Invatec Llc·June 12, 2013
lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
FDA Recall
Terminated
·Invatec Llc·Product code DXE·March 4, 2009
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
FDA Recall
Terminated
·Quidel Corporation·Product code PSZ·December 15, 2017
BBL Columbia C.N.A. Agar w/5% Sheep Blood - Catalog Number 297831.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Sheep Blood, Defibrinated - Catalog Number 212390, Unit 60 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Drager PT 4000 Phototherapy System
FDA Recall
Terminated
·Draeger Medical Systems, Inc.·Product code LBI·July 2, 2012
Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Sheep Blood, Defibrinated - Catalog Number 211945, Unit 15 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Sheep Blood, Defibrinated - Catalog Number 211946, Unit 100 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB - Catalog Number 295618.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
BBL Brain Heart Infusion Agar CC w/Sheep Blood - Catalog Number 296178.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004