69 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·August 9, 2017
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
FDA Enforcement
Class II
·Terminated·LivaNova Deutschland GmbH·July 8, 2020
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
FDA Enforcement
Class II
·Terminated·LivaNova Deutschland GmbH·July 8, 2020
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
FDA Enforcement
Class II
·Ongoing·LivaNova USA, Inc.·February 5, 2025
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc.·March 25, 2020