Abbott Medical - FDA 510(k) Cleared Devices
57
Total
57
Cleared
0
Denied
57 devices
Cleared
Jan 26, 2024
CentriMag™ Acute Circulatory Support System
Cardiovascular
29d
Cleared
Dec 19, 2023
JETi™Hydrodynamic Thrombectomy System
Cardiovascular
126d
Cleared
Sep 29, 2023
Amulet™ Steerable Delivery Sheath
Cardiovascular
28d
Cleared
Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with...
Cardiovascular
30d
Cleared
Aug 10, 2023
EnSite™ X EP System
Cardiovascular
86d
Cleared
Jun 30, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
Cardiovascular
29d
Cleared
Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
Cardiovascular
28d
Cleared
May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
Cardiovascular
104d
Cleared
May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
Cardiovascular
30d
Cleared
Apr 14, 2023
Dragonfly OpStar™ Imaging Catheter
Cardiovascular
58d
Cleared
Mar 01, 2023
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,...
Cardiovascular
28d
Cleared
Dec 27, 2022
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software...
Cardiovascular
88d
Cleared
Dec 19, 2022
ViewFlex Xtra Reprocessed ICE Catheter
Cardiovascular
147d
Cleared
Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
Cardiovascular
138d
Cleared
Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
Cardiovascular
14d
Cleared
Apr 30, 2022
Ultiri Measurement System
Cardiovascular
92d
Cleared
Apr 01, 2022
Aveir Retrieval Catheter
Cardiovascular
151d
Cleared
Mar 09, 2022
Amplatzer Steerable Delivery Sheath
Cardiovascular
30d
Cleared
Jan 21, 2022
Abbott Medical Grounding Pad, model RF-DGP-IS
Neurology
438d
Cleared
Nov 11, 2021
EnSite X EP System
Cardiovascular
30d
Cleared
Sep 27, 2021
Amplatzer Steerable Delivery Sheath
Cardiovascular
90d
Cleared
Sep 27, 2021
Amplatzer Talisman Delivery Sheath
Cardiovascular
28d
Cleared
Jul 27, 2021
Aveir Introducer
Cardiovascular
29d
Cleared
Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Cardiovascular
112d
Cleared
Nov 25, 2020
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled,...
Cardiovascular
121d