53 results
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20ms
·
Sources: EU EUDAMED, US FDA
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
UNO 102 EM/EE/ES Patient Lift
FDA Recall
Terminated
·Liko, Inc.·Product code FNG·September 24, 2004
Proteus 235 Proton Therapy System for cancer treatment.
FDA Recall
Terminated
·Product code IYE·March 27, 2014
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
BBL Brain Heart Infusion Agar w/10% Sheep Blood - Catalog Number 297655.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
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 Recall
Terminated
·Zimmer Biomet, Inc.·Product code KWY·August 25, 2017
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.
FDA Recall
Terminated
·Diamedix Corporation·Product code LGC·January 16, 2012
ROSA One 3.1 Brain Application
FDA Recall
Terminated
·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020