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Acumed, LLC

USA · Hillsboro

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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

31listed device types

Class I 11Class II 20Class III 0

plus 88 registration records and 38 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 10

32 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

40 including historic records

TWTaiwanTFDA

27valid device licences

Class I 3Class II 24

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

34active ARTG entries

Class I 12IIa 6IIb 14Class Im (measuring) 1Class Is (sterile) 1

HKHong KongMDACS

6valid listings

Class III 6

ILIsraelAMAR

1registrations

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 States88 registration records, 38 510(k), 0 PMA, 6 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: ACUMED LLC · ACUMED, LLC · ACUMED LLC. · ACUMED INC · Acumed LLC

FDA 510(k) clearances by year

12003

22004

22005

12006

22007

12009

12010

32011

22012

62013

42014

42015

12021

22022

12023

12024

42025

FDA listed device types

showing 8 of 31

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Cerclage, Fixation 1Screw, Fixation, Bone 1Washer, Bolt Nut 1Driver, Wire, And Bone Drill, Manual 1System, Image Processing, Radiological 1Pin, Fixation, Smooth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252356	The Acumed Wrist Fixation System - 2.4mm Screws	2025-08-21
US	K251132	The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws	2025-07-14
US	K251296	The Acumed Wrist Fixation System	2025-06-18
BR	80094170080	Kit Instrumental para Sistema Polarus 3 - ACUMED	Class I
BR	80094179003	KIT DE INTRUMENTAIS PARA CIRURGIA ORTOPÉDICA BIOTRAK	Class I
BR	80094170049	INSTRUMENTAIS PARA IMPLANTES ACUMED	Class I
SA	ME0000002157SFDAA00165	Acutrak 2® Mini Satellite Tray	—
SA	ME0000002157SFDAA00166	Acutrak 2® Standard Satellite Tray Assy	—

Acumed, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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