FDA Registration
Active
🇺🇸 United States
SAM MEDICAL PRODUCTS
Reg #: 3023316
·
FEI: 3023316
·
Expires 2026
Products
12
Proprietary Names
17
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- SAM MEDICAL PRODUCTS
- Registration Number
- 3023316
- FEI Number
- 3023316
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12200 Sw Tualatin Rd Ste 200
- City
- Tualatin
- State
- OR
- ZIP
- 97062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191488
Owner / Operator
- Firm Name
- SAM Medical Products
- Operator Number
- 3023316
- Address
- 12200 SW Tualatin Road, Suite 200
- City
- Tualatin
- State
- OR
- Postal Code
- 97062
- Country
- US
- Correspondent
- Siri Belur
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-11-17 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2011-03-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2021-01-19 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2003-12-03 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2015-02-26 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2025-12-11 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2020-04-30 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2017-02-17 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2018-06-13 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2007-12-19 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2015-05-21 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2025-12-11 |
Proprietary Names
SAM IO
SAM IO Intraosseous Access System; SAM IO
SAM Chest Seal with Valve
SAM Chest Seal
SAM Chest Seal Combo
SAM Chest Seal Valved 2
SAM ThoraSite
SAM Pelvic Sling II (SM, ST, LG, OD)
Chito-SAM Active
Chito-SAM 100
DART; PneumoDart; TPAK 10, TPAK
SAM IO Stabilizer
SAM XT; SAM XT Extremity Tourniquet; SAM Extremity Tourniquet
SAM Bleeding Control Kit
SAM Splint (multiple)
SAM Junctional Tourniquet
FP-909 TVAC - Manual Suction Device; TM-909 TVAC-Manual Suction Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device