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Abbott Medical

39 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software recall (Z-2405-2026)Abbott Medical2026-06-11
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 recall (Z-0458-2026)Abbott Medical2025-11-07
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 recall (Z-0459-2026)Abbott Medical2025-11-07
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 0541506704072 recall (Z-1557-2025)Abbott Medical2025-04-14
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portab recall (Z-0753-2025)Abbott Medical2024-12-23
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to trans recall (Z-0551-2025)Abbott Medical2024-11-26
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the recall (Z-0552-2025)Abbott Medical2024-11-26
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, recall (Z-0491-2025)Abbott Medical2024-11-20
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile recall (Z-0492-2025)Abbott Medical2024-11-20
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Steril recall (Z-0493-2025)Abbott Medical2024-11-20
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Steri recall (Z-0494-2025)Abbott Medical2024-11-20
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile recall (Z-0495-2025)Abbott Medical2024-11-20
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only recall (Z-2429-2024)Abbott Medical2024-07-25
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only recall (Z-2430-2024)Abbott Medical2024-07-25
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only recall (Z-2431-2024)Abbott Medical2024-07-25
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only recall (Z-2432-2024)Abbott Medical2024-07-25
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only recall (Z-2358-2024)Abbott Medical2024-07-16
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only recall (Z-2359-2024)Abbott Medical2024-07-16
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only recall (Z-2360-2024)Abbott Medical2024-07-16
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only recall (Z-2361-2024)Abbott Medical2024-07-16
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only recall (Z-2362-2024)Abbott Medical2024-07-16
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only recall (Z-2363-2024)Abbott Medical2024-07-16
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only recall (Z-2364-2024)Abbott Medical2024-07-16
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only recall (Z-2365-2024)Abbott Medical2024-07-16
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only recall (Z-2366-2024)Abbott Medical2024-07-16
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only recall (Z-2367-2024)Abbott Medical2024-07-16
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only recall (Z-2368-2024)Abbott Medical2024-07-16
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only recall (Z-2369-2024)Abbott Medical2024-07-16
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY recall (Z-2265-2024)Abbott Medical2024-07-03
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO recall (Z-1695-2024)Abbott Medical2024-04-29
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implant recall (Z-2614-2023)Abbott Medical2023-09-19
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrin recall (Z-2615-2023)Abbott Medical2023-09-19
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite recall (Z-2505-2023)Abbott Medical2023-09-11
Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite recall (Z-2506-2023)Abbott Medical2023-09-11
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable recall (Z-2507-2023)Abbott Medical2023-09-11
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable recall (Z-2508-2023)Abbott Medical2023-09-11
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pul recall (Z-2509-2023)Abbott Medical2023-09-11
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse recall (Z-2510-2023)Abbott Medical2023-09-11
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse recall (Z-2511-2023)Abbott Medical2023-09-11

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Every clearance here is in the API, with alerts when new ones post.