Abbott

FDA Filings

This page includes the latest FDA filings for Abbott. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Abbott (St. Jude Medical)
Mymerlin Mobile Application (android), Mymerlin Mobile Application (ios)2020-03-17
Abbott (formerly Thoratec Corporation)
Centrimag Circulatory Support System, Centrimag Return (arterial) Cannula Kit, Centrimag Drainage (venous) Cannula Kit2020-03-06
Abbott Point Of Care Inc.
I-STAT CHEM8+ Cartridge With The I-STAT 1 System2020-02-28
Abbott Point Of Care, Inc.
I-STAT CHEM8+ Cartridge With The I-STAT 1 System2020-02-14
Abbott Point Of Care Inc.
I-STAT CHEM8+ Cartridge With The I-STAT 1 System2020-02-07
Abbott Point Of Care, Inc.
I-STAT CHEM8+ Cartridge With The I-STAT 1 System2020-02-07
Abbott Point Of Care, Inc.
I-STAT CHEM8+ Cartridge With The I-STAT 1 System2020-02-07
Abbott Medical
ILUMIEN System With AptiVue Software Version D.32019-12-17
Abbott Vascular
HI-TORQUE InfilTrac Guide Wire Family2019-12-11
Abbott Medical
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.12019-11-08
Abbott
Confirm Rx Insertable Cardiac Monitor2019-10-18
Abbott Medical
Advisor VL Circular Mapping Catheter, Sensor Enabled2019-09-17
Abbott Laboratories Diagnostics Division
ARCHITECT STAT High Sensitivity Troponin-I2019-09-13
Abbott Vascular
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires2019-07-25
Abbott Diagnostics Scarborough, Inc.
ID NOW Influenza A & B 22019-07-11
Abbott
MitraClip G4 Steerable Guide Catheter2019-05-29
Abbott (St. Jude Medical)
Confirm Rx Insertable Cardiac Monitor2019-04-10
Abbott Medical
Amplatzer Treviso Intravascular Delivery System2019-04-05
Abbott
Confirm Rx Insertable Cardiac Monitor2019-03-29
Abbott Laboratories
CELL-DYN Emerald 22 AL System2019-03-15
Abbott
EnSite Velocity Cardiac Mapping System V5.2, EnSite Precision Cardiac Mapping System V2.22018-12-12
Abbott
EnSite Velocity Cardiac Mapping System V5.2, EnSite Precision Cardiac Mapping System V2.22018-10-19
Abbott Laboratories
Magnesium2018-09-12
Abbott Vascular
NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Cathete2018-08-24
Abbott Laboratories
Magnesium2018-05-18
Abbott Vascular
HI-TORQUE TurnTrac Guide Wire Family2018-01-12
Abbott Rapid Diagnostics
Alere Afinion HbA1c And ACR On Afinion 2 Analyzer2017-11-21
Abbott Laboratories
Abbott Architect Free T42017-10-27
Abbott Laboratories
Alinity C ICT Sample Diluent2017-10-24
ABBOTT LABORATORIES
Alinity I Total ß-hCG Reagent Kit, Alinity I System2017-10-23

Latest Premarket Applications

PMAManufacturerDevice NameDate
Abbott
CentriMag Circulatory Support System2020-03-20
ABBOTT VASCULAR
MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS2020-03-19
ABBOTT VASCULAR INC.
XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS2020-03-19
ABBOTT VASCULAR
XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE2020-03-12
ABBOTT VASCULAR INC.
XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System2020-03-12
Abbott Medical
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)2020-03-04
Abbott Medical
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)2020-03-04
ABBOTT VASCULAR INC.
MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System2020-02-26
ABBOTT VASCULAR
Xience Sierra Everolimus Eluting Coronary Stent System2020-02-13
Abbott Medical
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG.2020-01-10
Abbott Medical
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG2020-01-10
Abbott Medical
Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG2020-01-10
Abbott Laboratories
Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory2020-01-07
Abbott Diabetes Care Inc.
FreeStyle Libre Pro Flash Glucose Monitoring System2019-12-16
ABBOTT DIABETES CARE INC.
Freestyle Libre 14-day Flash Glucose Monitoring System2019-12-16
ABBOTT VASCULAR INC.
MULTI-LINK ULTRA RX Coronary Stent System2019-12-13
Abbott
CentriMag Circulatory Support System2019-12-06
ABBOTT LABORATORIES INC
ARCHITECT AUSAB, LN 1L822019-12-03
Abbott Medical
Brio Neurostimulation System2019-11-19
Abbott Medical
Genesis Neurostimulation System2019-11-19
Abbott Medical
Axium Neurostimulator System2019-11-19
Abbott Molecular, Inc.
Abbott RealTime IDH1 Assay2019-11-12
Abbott Medical
Amplatzer Muscular VSD Occluder2019-10-25
Abbott Medical
Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder2019-10-25
Abbott Medical
Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder2019-10-25
Abbott Medical
Amplatzer PFO Occluder2019-10-25
ABBOTT VASCULAR INC.
MitraClip G4 Clip Delivery System2019-09-30
Abbott Medical
Torque Wrench2019-09-26
Abbott Molecular Inc.
RealTime IDH22019-09-24
Abbott Molecular, Inc.
RealTime IDH12019-09-24

Latest De Novo Filings

De NovoManufacturerDevice NameDate
ABBOTT MOLECULAR, INC.
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)2013-07-29

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
AlinIQ
ABBOTT SRL2020-03-24
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
Armada
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
Armada
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
Armada
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
Armada
ABBOTT VASCULAR INC.2020-03-23
TREK
ABBOTT VASCULAR INC.2020-03-23
Armada
ABBOTT VASCULAR INC.2020-03-23

Related Finance Registrations

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