269 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 21, 2018
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 2, 2016
NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·September 29, 2017
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·January 18, 2016
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
FDA Enforcement
Class II
·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
FDA Enforcement
Class II
·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·May 17, 2010
SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·Cell Marque Corporation·June 7, 2017
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Recall
Terminated
·MTI Precision Products LLC.·Product code EFB·May 7, 2012
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Enforcement
Class II
·Terminated·MTI Precision Products LLC.·July 23, 2014
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 10, 2011
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006
Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 6, 2005
Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2003