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Medical Designs, LLC

USA · Sioux Falls

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, 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

27listed device types

Class I 13Class II 14Class III 0

plus 38 registration records and 79 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

3active device licences

Class II 2Class III 1

5 including historic records

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 States38 registration records, 79 510(k), 0 PMA, 59 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada3 confirmed, 2 excluded

Manufacturer names merged into this page: ADVANCE MEDICAL DESIGNS, INC. · STANLEY MEDICAL DESIGNS, INCORPORATED · INRO MEDICAL DESIGNS, INC. · SPECTRUM DESIGNS INC. ALSO TRADING AS SPECTRUM DESIGNS MEDICAL · MEDICAL DESIGNS, LLC · Advance Medical Designs Inc

FDA 510(k) clearances by year

71984

81985

11986

81989

111990

21991

51992

11993

31994

21995

12000

42001

12004

22006

12009

12012

12015

12017

22018

12023

FDA listed device types

showing 8 of 27

Cover, Limb 1Protector, Skin Pressure 1Container, Specimen, Non-Sterile 1Head Halter, Traction 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Stretcher, Patient Restraint 1Guide, Needle, Surgical 1Bedding, Disposable, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223689	Disposable Needle Guides and Grids	2023-08-02
US	K182352	SP-LINK System	2018-11-21
US	K181591	Fixated Asfora BULLET CAGE® (FABC)	2018-09-26
SA	ME0000013174SFDAA00001	Infection Control System	—
SA	ME0000012832SFDAA00003	Patient Positioning Belt	—
CA	62985	PRESSURE MONITORING LINE	Class II
CA	29245	SOLID SILICONE FACIAL IMPLANTS	Class III
CA	74310	SILICONE FACIAL SIZERS	Class II

Medical Designs, 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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