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"
121–144 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 01, 2022
Aveir Retrieval Catheter
K213494 · MMX
Abbott Medical
Cardiovascular · 151d
Cleared Mar 22, 2022
Creatinine2
K210452 · CGX
Abbott Ireland Diagnostics Division
Chemistry · 399d
Cleared Mar 18, 2022
Albumin BCP2
K203530 · CJW
Abbott Ireland Diagnostics Division
Chemistry · 471d
Cleared Mar 10, 2022
GLP systems Track
K213486 · JGS
Abbott Laboratories
Chemistry · 132d
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 23, 2021
Albumin BCG2
K203248 · CIX
Abbott Ireland Diagnostics Division
Chemistry · 384d
Cleared Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 237d
Cleared Nov 11, 2021
EnSite X EP System
K213364 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Oct 22, 2021
EnSite X EP System
K212061 · DQK
Abbott
Cardiovascular · 113d
Cleared Sep 27, 2021
Amplatzer Talisman Delivery Sheath
K212738 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 27, 2021
Amplatzer Steerable Delivery Sheath
K212026 · DQY
Abbott Medical
Cardiovascular · 90d
Cleared Aug 13, 2021
Jot Dx Insertable Cardiac Monitor
K212206 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 29d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · CGA
Abbott Point of Care, Inc.
Chemistry · 135d
Cleared Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 120d
Cleared Jul 30, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K201761 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 396d
Cleared Jul 27, 2021
Aveir Introducer
K211989 · DYB
Abbott Medical
Cardiovascular · 29d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · NQQ
Abbott Medical
Cardiovascular · 112d
Cleared Mar 11, 2021
WorkMate Claris System
K210392 · DQK
Abbott
Cardiovascular · 29d
Cleared Jan 08, 2021
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · QAT
Abbott Laboratories
Immunology · 192d
Cleared Dec 01, 2020
Confirm Rx Insertable Cardiac Monitor
K202876 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 64d
Cleared Nov 25, 2020
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled,...
K202066 · DQK
Abbott Medical
Cardiovascular · 121d
Cleared Nov 23, 2020
Confirm Rx Insertable Cardiac Monitor
K202888 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 56d
Cleared Oct 21, 2020
IonicRF Generator
K201610 · GXD
Abbott Medical
Neurology · 128d