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Instrumed International, Inc.

USA · Schaumburg

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

241listed device types

Class I 212Class II 29Class III 0

plus 264 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States264 registration records, 7 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Instrumed International Inc dba Avalign German Specialty Instruments

FDA 510(k) clearances by year

12004 · K040855

12007 · K071771

12008 · K081651

22009 · K092840

22010 · K100518

FDA listed device types

showing 8 of 241

Electrosurgical, Cutting & Coagulation & Accessories 1Forceps, Surgical, Gynecological 1Screw, Fixation, Bone 1Retractor, Self-Retaining, For Neurosurgery 1Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Laparoscope, General & Plastic Surgery 1Dilator, Vessel, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K100518	INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054	2010-08-31
US	K100517	INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX	2010-04-29
US	K092840	INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL	2009-12-03

Instrumed International, Inc.

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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