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Sam® Medical Products, Inc.

USA · Tualatin

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel — 8 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

12listed device types

Class I 9Class II 2Class III 0unclassified 1

plus 13 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

11valid device licences

Class I 9Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 7IIa 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

15registrations

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 States13 registration records, 5 510(k), 0 PMA, 10 excluded

Brazil8 confirmed, 1 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SAM MEDICAL PRODUCTS · SAM Medical Products

FDA 510(k) clearances by year

12011 · K102403

22013 · K131561

12014 · K133121

12019 · K191488

FDA listed device types

showing 8 of 12

Tourniquet Kit 1Splint, Extremity, Non-Inflatable, External, Non-Sterile 1Dressing, Wound, Occlusive 1Device, Intravascular Catheter Securement 1Needle, Aspiration And Injection, Disposable 1Orthosis, Sacroiliac, Soft 1Catheters, Suction, Tracheobronchial 1Catheter, Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191488	SAM IO Intraosseous Access System	2019-11-21
US	K133121	CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT	2014-05-22
US	K131561	SAM JUNCTIONAL TOURNIQUET	2013-07-24
BR	10209780121	Torniquete Pelvico SAM	Class I
BR	80469670009	Chest Seal	Class I
BR	80469670010	TALA SAM	Class I
SA	ME0000013556SFDAA00008	SAM PELVIC SLING II	—
SA	ME0000013556SFDAA00006	SAM XT EXTREMITY TOURNIQUET	—
CA	94499	CHITO-SAM ACTIVE HEMOSTATIC DRESSING	Class II

Sam® Medical Products, 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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