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

1,305 results for "abbott"
97–120 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 21, 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
K223537 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Dec 29, 2022
Total Bilirubin2
K223324 · CIG
Abbott Ireland Diagnostics Division
Chemistry · 59d
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 Dec 08, 2022
CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
K222038 · QNR
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 150d
Cleared Dec 01, 2022
CentriMag Pre-connected Pack
K222297 · DTZ
Abbott
Cardiovascular · 122d
Cleared Oct 27, 2022
Architect CMV IgG
K220949 · LFZ
Abbott Laboratories
Microbiology · 209d
Cleared Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
K221397 · DRA
Abbott Medical
Cardiovascular · 138d
Cleared Aug 18, 2022
EnSite X EP System
K221213 · DQK
Abbott
Cardiovascular · 113d
Cleared Aug 12, 2022
Unistik® 3, sterile single-use safety lancets
K221126 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 116d
Cleared Jul 15, 2022
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....
K212778 · QLX
Abbott Molecular, Inc.
Microbiology · 317d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750 · DQY
Abbott Medical
Cardiovascular · 14d
Cleared Jun 30, 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · LOX
Abbott Vascular
Cardiovascular · 118d
Cleared Jun 30, 2022
Cholesterol2
K203597 · CHH
Abbott Ireland Diagnostics Division
Chemistry · 568d
Cleared Jun 24, 2022
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
K220801 · OZE
Abbott Diagnostics Scarborough, Inc.
Microbiology · 98d
Cleared May 31, 2022
Urea Nitrogen2
K203771 · CDQ
Abbott Ireland Diagnostics Division
Chemistry · 524d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K212132 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 322d
Cleared May 26, 2022
Amylase2
K210633 · JFJ
Abbott Ireland Diagnostics Division
Chemistry · 449d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596 · LGD
Abbott Laboratories
Microbiology · 444d
Cleared May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
K202525 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 625d
Cleared May 05, 2022
Viatrac 14 Plus Peripheral Dilatation Catheter
K221057 · LIT
Abbott Vascular
Cardiovascular · 24d
Cleared Apr 30, 2022
Ultiri Measurement System
K220243 · DQK
Abbott Medical
Cardiovascular · 92d
Cleared Apr 29, 2022
Alinity m STI Assay
K202977 · QEP
Abbott Molecular, Inc.
Microbiology · 576d