Medical Device Manufacturer · US , S,Mta Clara , CA

Abbott Medical - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 2019

Recent clearances: EnSite™ X EP System, EnSite™ X EP System, Amplatzer TorqVue Exchange System

View 60 510(k) Devices ↓ Official Website

60

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Medical Neurology ✕

4 devices

1-4 of 4

Cleared Apr 16, 2026

Disposable Radiofrequency Cannula

Neurology · 132d

Cleared May 27, 2025

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

Neurology · 250d

Cleared Jan 21, 2022

Abbott Medical Grounding Pad, model RF-DGP-IS

Neurology · 438d

Cleared Oct 21, 2020

IonicRF Generator

Neurology · 128d