32 results
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Sources: EU EUDAMED, US FDA
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Various Sizes of Sterile Polyglycolic Acid Synthetic Surgical Suture-NDR, POLYGLY 2-0 C-2/CST43 2N36, Catalog #833-135
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code ndr·March 31, 2011
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code ndr·March 31, 2011
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code ndr·March 31, 2011
Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code NDR·November 10, 2010
Inhibin A ELISA kit, Part Number: DSL-10-28100T-4 The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code NDR·December 21, 2010
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code ndr·March 31, 2011
Inhibin A ELISA kit, Part Number: DSL-10-28100-4 The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code NDR·December 21, 2010
Plicator EPS Plication System Catalog Number: 160-01128R
FDA Recall
Terminated
·NDO Surgical, Inc.·Product code KOG·January 26, 2007
PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
FDA Recall
Terminated
·Guidant Corporation·Product code KRG·June 16, 2005
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Recall
Terminated
·LDR Spine USA, Inc.·Product code LXH·August 29, 2016
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Enforcement
Class II
·Terminated·LDR Spine USA, Inc.·October 12, 2016
Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
FDA Recall
Terminated
·ela Medical Llc·Product code MRM·July 19, 2005
Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code LWP·March 16, 2007
Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
FDA Recall
Terminated
·Guidant Corporation·Product code KRG·June 17, 2005
VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, model A155. VITALITY DS DR/VR (Models T125, T135), VITALITY 2 DR/VR (Models T165, T175) and VITALITY 2 EL DR/VR (Models T167, T177) Implantable Cardioverter Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code KRG·March 15, 2010
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.
FDA Recall
Terminated
·Anthogyr 2237 Avenue Andre Lasquin Sallanches France·Product code DZE·June 20, 2016
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.
FDA Recall
Terminated
·Anthogyr 2237 Avenue Andre Lasquin Sallanches France·Product code DZE·June 20, 2016
VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR HE, model 1853 and 1858, PRIZM VR HE, model 1857, PRIZM 2 VR model 1860 and PRIZM 2 DR model 1861. The ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA
FDA Recall
Terminated
·Boston Scientific CRM Corp·Product code LWP·March 15, 2010