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Abbott Medical

USA · Plymouth

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

84listed device types

Class I 11Class II 37Class III 36

plus 335 registration records and 84 510(k), 3,640 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

40registered devices

Class I 17Class II 23

237 including historic records

SASaudi ArabiaSFDA

5registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

13active device licences

Class II 11Class III 1Class IV 1

245 including historic records

TWTaiwanTFDA

92valid device licences

Class I 3Class II 57Class III 32

SGSingaporeHSA SMDR

122device registrations

CLASS B 11CLASS C 15CLASS D 82D WITH MEDICINAL PRODUCT 14

KRSouth KoreaMFDS GMP

29GMP quality-system certificates

Import 29

AUAustraliaTGA ARTG

424active ARTG entries

Class I 23Class III 316IIa 27IIb 39Class Is (sterile) 19

HKHong KongMDACS

135valid listings

Class II 13Class III 22Class IV 100

ILIsraelAMAR

74registrations

RURussiaRoszdravnadzor

76active registrations

Class 2a 2Class 2b 9Class 3 65

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 States335 registration records, 84 510(k), 3,640 PMA, 55 excluded

Brazil40 confirmed, 27 excluded

Saudi Arabia5 confirmed, 1 excluded

Canada13 confirmed, 28 excluded

Manufacturer names merged into this page: Abbott Medical · ABBOTT MEDICAL · Abbott Medical Costa Rica Ltda. · Abbott Medical Costa Rica Limitada (Structural Heart) · ABBOTT DIAGNOSTICS MEDICAL CO., LTD. · ABBOTT MEDICAL COSTA RICA LTD

FDA 510(k) clearances by year

11979

11980

12010

42011

22012

12014

32015

12016

22017

12018

72019

82020

62021

82022

102023

82024

132025

72026

FDA listed device types

showing 8 of 84

Sizer, Heart-Valve, Prosthesis 1Instrument, Surgical, Disposable 1Holder, Heart-Valve, Prosthesis 1Magnet, Test, Pacemaker 1Tools, Pacemaker Service 1Tape, Measuring, Rulers And Calipers 1Cardiovascular Delivery Catheter System Positioning And Stabilization Device 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262006	EnSite X EP System	2026-07-15
US	K261631	Amplatzer TorqVue Exchange System	2026-06-17
US	K253459	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
BR	10332340471	Electrophysiology Cable	Class I
BR	10332340414	Cabo Adaptador NeuroTherm	Class I
BR	10332340500	Agilis HisPro Slitter	Class I
SA	ME0000014762SFDAA00006	Lift	—
SA	ME0000014762SFDAA00004	Stabilizer	—
CA	1345	FAST-CATH(TM) HEMOSTASIS INTRODUCERS	Class II
CA	27298	ULTIMUM HEMOSTASIS INTRODUCER	Class II
CA	69836	ABBOTT MEDICAL VESSEL DILATORS	Class II