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SAM Medical Products

United States·US-MF-000002589

Last updated September 17, 2026

Information

Country: United States
Address: 12200 SW Tualatin Road, Tualatin, United States
Website: sammedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Kyle Sims
EUDAMED SRN: US-MF-000002589
FDA FEI Number: 3023316
DUNS Number: —

Catalogue (101)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
SAM Splint	SP527-OB-EN-803	FDA UDI	Class I	Active
Chito-SAM™ 100	CT100-B-EN	FDA UDI	U	Active
SAM Splint	SP526-BC-EN-705	FDA UDI	Class I	Active
SAM Splint	SP527-CH-EN-773	FDA UDI	Class I	Active
SAM Splint	SP526-OB-EN-772	FDA UDI	Class I	Active
SAM(R) Junctional Tourniquet	SJT101	FDA UDI	Class II	Unknown
SAM Soft Shell Splint	SS544-EN	FDA UDI	Class I	Active
SAM Splint	SP504-OB-EN	FDA UDI	Class I	Active
SAM Splint	SP526-OB-EN-568	FDA UDI	Class I	Active
SAM® Junctional Tourniquet	JT403-EN	FDA UDI	Class II	Active
SAM IO Intraosseous Access System	IO740-5P-EN	FDA UDI	Class I	Active
SAM Sugar Tong Splint	ST561-EN	FDA UDI	Class I	Active
SAM(R) Junctional Tourniquet	SJT115	FDA UDI	Class II	Unknown
SAM Soft Shell Splint XL	SS545-EN	FDA UDI	Class I	Active
SAM(R) Junctional Tourniquet	SJT114	FDA UDI	Class II	Unknown
SAM Sugar Tong Splint	ST562-EN	FDA UDI	Class I	Active
SAM Soft Shell Splint	SS540-EN	FDA UDI	Class I	Active
SAM ThoraSite®	TS200-1P	EUDAMED	Class I	Active
SAM® Splint XL	SP508-OB-DE	EUDAMED	Class I	Active
SAM® Splint	SP500-CH-EN	EUDAMEDFDA UDI	Class I	Active
SAM® XT Extremity Tourniquet	XT700-BL-EN	EUDAMEDFDA UDI	Class I	Active
National-Standard Needle Holder	K881956	FDA 510(k)	Class II	Active
Tru-Trac Torque Guidewire	K880288	FDA 510(k)	Class II	Active
Tru-Trac Coiled Guidewire	K880287	FDA 510(k)	Class II	Active
Sam Chest Seal With Vavle; Sam Chest Seal	K102403	FDA 510(k)	Class I	Active
Hawkins Breast Localization Needle	K870523	FDA 510(k)	Class I	Active
SAM IO Intraosseous Access System	K191488	FDA 510(k)	Class II	Active
Hawkins-Akins Blunt Needle Access Kit	K881957	FDA 510(k)	Class II	Active
Chito-Sam 100, 4in X4in, Chito-Sam, 3in X6ft, Chito-Sam 100, 3in X10ft, Chito-Sam Active, 4inx4in, Chito-Sam Active, 3inx6ft	K133121	FDA 510(k)	U	Active
SAM® Pelvic Sling II	PS300-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® XT Extremity Tourniquet	XT600-BL-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Pelvic Sling II	PS301-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Pelvic Sling II	PS302-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Junctional Tourniquet	JT400-EN	EUDAMEDFDA UDI	Class I	Active
SAM® XT Extremity Tourniquet	XT700-OR-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint	SP506-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® XT Extremity Tourniquet	XT700-BK-EN	EUDAMEDFDA UDI	Class I	Active
SAM® XT Extremity Tourniquet	XT600-BK-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Junctional Tourniquet	JT401-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint	SP507-OB-DE	EUDAMED	Class I	Active
SAM® Pelvic Sling II	PS301-OD-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint XL	SP508-CH-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint	SP506-CH-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint	SP507-CH-DE	EUDAMED	Class I	Active
SAM® Splint	SP507-CH-EN	EUDAMEDFDA UDI	Class I	Active
SAM® XT Extremity Tourniquet	XT600-OR-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Finger Splint	SP510-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint XL	SP508-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint	SP500-OB-EN	EUDAMEDFDA UDI	Class I	Active
SAM® Splint	SP502-CH-EN	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 28, 2022	Z-0789-2022	—	terminated	Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
Aug 14, 2014	Z-0133-2015	—	terminated	SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.