Medical Device Manufacturer · US , Wilsonville , OR

Sam Medical Products - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2011

Recent clearances: CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT, SAM JUNCTIONAL TOURNIQUET, SAM JUNCTIONAL TOURNIQUET

4
Total
4
Cleared
0
Denied

Sam Medical Products, is an emergency medical solutions company specializing in trauma care and first responder equipment. Based in Wilsonville, Oregon, the company develops and manufactures devices for hemorrhage control, fracture stabilization, and respiratory management used by militaries, law enforcement, EMS, and hospital systems worldwide.

The company has received 4 FDA 510(k) clearances from 4 total submissions between 2011 and 2014. Sam Medical's cleared devices span Cardiovascular and General & Plastic Surgery categories, including tourniquets, hemostatic gauze products, and chest seals. The company is currently inactive with no new clearances in more than a decade, making this a historical regulatory record.

Notable cleared products include the SAM Junctional Tourniquet, CHITO-SAM hemostatic gauze in multiple configurations, and SAM Chest Seal with Valve. The company's product portfolio also encompasses splints, pelvic slings, and bleeding control kits designed for emergency field use.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review Sam Medical's regulatory history.

FDA 510(k) Regulatory Record - Sam Medical Products

4 devices
1-4 of 4
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