Abbott Medical
86 FDA actions
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Abbott Medical
Amplatzer TorqVue Exchange System
Abbott Medical
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade
ABBOTT MEDICAL
EnSite X EP System
ABBOTT MEDICAL
Disposable Radiofrequency Cannula
ABBOTT MEDICAL
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-A
ABBOTT MEDICAL
Armada 14 NC PTA Catheter
ABBOTT MEDICAL
Assert-IQ (DM5100)
ABBOTT MEDICAL
Amplatzer Piccolo Delivery System (9-PDS-04F-045)
ABBOTT MEDICAL
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Abbott Medical
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Abbott Medical
Seguin Annuloplasty Ring
ABBOTT MEDICAL
Amplatzer Guidewire
ABBOTT MEDICAL
EnSite X EP System
ABBOTT MEDICAL
EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Soft
ABBOTT MEDICAL
EnSite X EP System
ABBOTT MEDICAL
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
ABBOTT MEDICAL
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
ABBOTT MEDICAL
ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled;
ABBOTT MEDICAL
ViewFlex X ICE Catheter, Sensor Enabled
ABBOTT MEDICAL
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI cod
Abbott Medical
JETi Hydrodynamic Thrombectomy System
ABBOTT MEDICAL
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming
Abbott Medical
MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
ABBOTT MEDICAL
Agilis NxT Steerable Introducer Dual-Reach
ABBOTT MEDICAL
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the p
Abbott Medical
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capa
Abbott Medical
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Abbott Medical
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Abbott Medical
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Abbott Medical
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Abbott Medical
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Abbott Medical
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
ABBOTT MEDICAL
TriClip Steerable Guide Catheter
ABBOTT MEDICAL
EnSite X EP System
ABBOTT MEDICAL
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Abbott Medical
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Abbott Medical
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Abbott Medical
Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Abbott Medical
Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
Abbott Medical
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Abbott Medical
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Abbott Medical
Advisor HD Grid X Mapping Catheter, Sensor Enabled
ABBOTT MEDICAL
Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
ABBOTT MEDICAL
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Abbott Medical
CentriMag Acute Circulatory Support System
ABBOTT MEDICAL
JETiHydrodynamic Thrombectomy System
ABBOTT MEDICAL
Amulet Steerable Delivery Sheath
ABBOTT MEDICAL
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrilla
Abbott Medical
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchroniza
Abbott Medical
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a
Abbott Medical
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product
Abbott Medical
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele
Abbott Medical
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an ele
Abbott Medical
Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description:
Abbott Medical
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an e
Abbott Medical
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is a
Abbott Medical
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
ABBOTT MEDICAL
EnSite X EP System
ABBOTT MEDICAL
ViewFlex Eco Reprocessed ICE Catheter
ABBOTT MEDICAL
CPS Direct Universal slittable outer guide catheter (DS2C029)
ABBOTT MEDICAL
Assert-IQ Insertable Cardiac Monitor
ABBOTT MEDICAL
ViewFlex Eco Reprocessed ICE Catheter
ABBOTT MEDICAL
Dragonfly OpStar Imaging Catheter
ABBOTT MEDICAL
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 40
ABBOTT MEDICAL
EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Abla
ABBOTT MEDICAL
MitraClip G4 Steerable Guide Catheter
ABBOTT MEDICAL
CPS AIM Universal II Slittable Inner Catheter
ABBOTT MEDICAL
Ultiri Measurement System
ABBOTT MEDICAL
Aveir Retrieval Catheter
ABBOTT MEDICAL
Amplatzer Steerable Delivery Sheath
ABBOTT MEDICAL
Abbott Medical Grounding Pad, model RF-DGP-IS
ABBOTT MEDICAL
EnSite X EP System
ABBOTT MEDICAL
Amplatzer Talisman Delivery Sheath
ABBOTT MEDICAL
Amplatzer Steerable Delivery Sheath
ABBOTT MEDICAL
Aveir Introducer
ABBOTT MEDICAL