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Abbott Vascular Devices

USA · Redwood
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
40listed device types
Class I 4Class II 24Class III 11unclassified 1
plus 326 registration records and 64 510(k), 930 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 3Class II 3
17 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
58active device licences
Class II 18Class III 4Class IV 36
118 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States326 registration records, 64 510(k), 930 PMA, 60 excluded
Brazil6 confirmed, 29 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada58 confirmed, 25 excluded
Manufacturer names merged into this page: ABBOTT VASCULAR · Abbott Vascular Netherlands · Abbott Vascular · ABBOTT LABORATORIES, ABBOTT VASCULAR INC. · ABBOTT IRELAND VASCULAR DIVISION · ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND GMBH
Same-named companies — This database also contains companies with near-identical names: Abbott Vascular, Inc., Abbott Vascular-Vascular Solutions. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Redwood

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22001
22002
22003
22005
12006
22007
72008
82009
52010
72011
52012
22013
32014
42015
12016
22017
22018
22019
22020
22022

FDA listed device types

showing 8 of 40
Bottle, Collection, Vacuum 1Catheter, Intravascular, Diagnostic 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Transducer, Pressure, Catheter Tip 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Syringe, Balloon Inflation 1Catheter, Angioplasty, Peripheral, Transluminal 1Computer, Diagnostic, Programmable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220634NC TREK NEO Coronary Dilatation Catheter2022-06-30
USK221057Viatrac 14 Plus Peripheral Dilatation Catheter2022-05-05
USK201834HI-TORQUE PROCEED Guide Wire Family2020-07-30
BR80146509042STABILIZERClass I
BR80146509040SUPPORT PLATEClass I
BR80146501771H-I TORQUE VERSACORE 035 GUIDE WIREClass II
CA68139SUTURE TRIMMERSClass IV
CA11181KNOT PUSHERClass II
CA14494HEARTFLO ANASTOMOSIS DEVICE (MECHANICALLY DRIVEN)Class IV

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