19 results
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12ms
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Sources: EU EUDAMED, US FDA
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
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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014
Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Enforcement
Class II
·Terminated·TP Orthodontics, Inc.·May 16, 2018