FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
121–144 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Jul 30, 2020
HI-TORQUE PROCEED Guide Wire Family
K201834 · DQX
Abbott Vascular
Cardiovascular · 28d
Cleared Jun 26, 2020
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
K201181 · DQK
Abbott Medical
Cardiovascular · 57d
Cleared Jun 26, 2020
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software...
K201148 · DQK
Abbott Medical
Cardiovascular · 58d
Cleared Jun 12, 2020
FreeStyle Libre 2 Flash Glucose Monitoring System
K193371 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 190d
Cleared Jun 03, 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · DQY
Abbott (St. Jude Medical)
Cardiovascular · 76d