42 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Merlin.net model MN5000 Software
FDA Enforcement
Class II
·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·August 10, 2022
Merlin 2 PCS MER37000 programmer Model MER3400 software
FDA Enforcement
Class II
·Ongoing·St. Jude Medical, Cardiac Rhythm Management Division·August 10, 2022
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025
Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·April 23, 2025
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
FDA Enforcement
Class II
·Ongoing·Abbott Medical·November 27, 2024
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
FDA Enforcement
Class II
·Ongoing·Abbott Medical·November 27, 2024
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
FDA Enforcement
Class III
·Ongoing·Abbott Medical·December 4, 2024
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
FDA Enforcement
Class II
·Ongoing·Abbott Medical·November 27, 2024
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
FDA Enforcement
Class III
·Ongoing·Abbott Medical·December 4, 2024
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
FDA Enforcement
Class II
·Ongoing·Abbott Medical·November 27, 2024
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
FDA Enforcement
Class II
·Ongoing·Abbott Medical·November 27, 2024
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 31, 2024
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 31, 2024
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 10, 2024