16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.
FDA Recall
Terminated
·Ferndale Laboratories, Inc.·Product code KOX·July 7, 2010
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·April 1, 2016