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Engineered Medical Systems, Inc.

USA · Indianapolis

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan — 5 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

97listed device types

Class I 29Class II 66Class III 1unclassified 1

plus 112 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

8active device licences

Class II 8

TWTaiwanTFDA

1valid device licences

Class II 1

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 States112 registration records, 24 510(k), 0 PMA, 16 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada8 confirmed, 3 excluded

Manufacturer names merged into this page: Engineered Medical Systems, LLC · ENGINEERED MEDICAL SYSTEMS INC. · ENGINEERED MEDICAL SYSTEMS · Engineered Medical Systems

FDA 510(k) clearances by year

21987

21991

51993

11998

41999

32000

42002

12003

12007

12022

FDA listed device types

showing 8 of 97

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1System, Network And Communication, Physiological Monitors 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Posterior Metal/Polymer Spinal System, Fusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220533	Endoscopy Oxygen Mask	2022-11-16
US	K062104	TALKING TRACH	2007-04-20
US	K023683	MULTI-STRAP FULL FACE MASK	2003-12-01
BR	81591129001	Laringe Eletrônica Blom Singer®	Class II
SA	ME0000002294SFDAA00003	Electrolarynx	—
CA	60979	TRACHVOX	Class II
CA	61346	OSA MASKS (OBSTRUCTIVE SLEEP APNEA)	Class II
CA	61382	AIRSEAL MASKS	Class II

Engineered Medical Systems, 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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