Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

79 results for "Abbott Medical"
25–48 of 79
Search insights Median review: 88d Cleared: 100% Top manufacturer: Abbott Medical Lead specialty: Cardiovascular
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538 · DQY
Abbott Medical
Cardiovascular · 88d
Cleared Aug 09, 2024
EnSite™ X EP System
K242016 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jul 09, 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · MTD
Abbott Medical
Cardiovascular · 55d
Cleared Jun 13, 2024
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
K241370 · DYB
Abbott Medical
Cardiovascular · 30d
Cleared Jan 26, 2024
CentriMag™ Acute Circulatory Support System
K234118 · QNR
Abbott Medical
Cardiovascular · 29d
Cleared Dec 19, 2023
JETi™Hydrodynamic Thrombectomy System
K232458 · QEZ
Abbott Medical
Cardiovascular · 126d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with...
K232386 · NQQ
Abbott Medical
Cardiovascular · 30d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d
Cleared Jun 30, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · OWQ
Abbott Medical
Cardiovascular · 29d
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
K230286 · MXC
Abbott Medical
Cardiovascular · 104d
Cleared May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · OWQ
Abbott Medical
Cardiovascular · 30d
Cleared Apr 14, 2023
Dragonfly OpStar™ Imaging Catheter
K230411 · DQO
Abbott Medical
Cardiovascular · 58d
Cleared Mar 01, 2023
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,...
K230283 · DYB
Abbott Medical
Cardiovascular · 28d
Cleared Dec 27, 2022
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software...
K223094 · DQK
Abbott Medical
Cardiovascular · 88d
Cleared Dec 19, 2022
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · OWQ
Abbott Medical
Cardiovascular · 147d
Cleared Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
K221397 · DRA
Abbott Medical
Cardiovascular · 138d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750 · DQY
Abbott Medical
Cardiovascular · 14d
Cleared Apr 30, 2022
Ultiri Measurement System
K220243 · DQK
Abbott Medical
Cardiovascular · 92d
Cleared Apr 01, 2022
Aveir Retrieval Catheter
K213494 · MMX
Abbott Medical
Cardiovascular · 151d
Cleared Mar 09, 2022
Amplatzer Steerable Delivery Sheath
K220340 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Jan 21, 2022
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293 · GXD
Abbott Medical
Neurology · 438d
Cleared Nov 11, 2021
EnSite X EP System
K213364 · DQK
Abbott Medical
Cardiovascular · 30d