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Sources: EU EUDAMED, US FDA
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Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428, Size (Fr) 28, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·March 25, 2020
CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response.
FDA Recall
Terminated
·iCAD, Inc.·Product code LNH·December 9, 2008
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
FDA Recall
Terminated
·Freudenberg Medical, Llc·Product code DYB·February 21, 2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
FDA Recall
Terminated
·Freudenberg Medical, Llc·Product code DYB·February 21, 2022
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
FDA Enforcement
Class I
·Terminated·Laax, Inc.·April 29, 2015
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
FDA Enforcement
Class I
·Terminated·Laax, Inc.·April 29, 2015
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
FDA Recall
Terminated
·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JHX·November 11, 2015
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·December 19, 2017
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IOQ·November 4, 2009
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code LWS·February 12, 2020
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
FDA Recall
Terminated
·ela Medical Llc·Product code LWS·January 25, 2005
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
FDA Recall
Terminated
·ela Medical Llc·Product code LWS·January 25, 2005