Sam Medical Products
Tualatin, OR, US
SAM MEDICAL PRODUCTS appears in FDA device records in Tualatin, OR. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Sam Medical Products carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- The Seaberg Company Incenforcement report, recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Sam Medical Products between 2011 and 2019. The busiest year on record is 2013, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191488 | SAM IO Intraosseous Access System | FMI | Substantially Equivalent | |
| K133121 | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT | QSY | Substantially Equivalent | |
| K131561 | SAM JUNCTIONAL TOURNIQUET | DXC | Substantially Equivalent | |
| K123694 | SAM JUNCTIONAL TOURNIQUET | DXC | Substantially Equivalent | |
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | NAD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3023316 | 3023316 | SAM MEDICAL PRODUCTS | 12200 Sw Tualatin Rd Ste 200, Tualatin, OR 97062 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GBXCatheter, Irrigation
- BSYCatheters, Suction, Tracheobronchial
- DXCClamp, Vascular
- KMKDevice, Intravascular Catheter Securement
- NADDressing, Wound, Occlusive
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- IPWOrthosis, Sacroiliac, Soft
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile
- OJSTourniquet Kit
- GAXTourniquet, Nonpneumatic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0789-2022 | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 | 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. | Class II | Terminated | |
| Z-2228-2018 | Part #: SAM XT-C, Model: Hi-Viz Blue | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device. | Class II | Terminated | |
| Z-2227-2018 | Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device. | Class II | Terminated | |
| Z-2226-2018 | Part #: SAM XT-M, Model: Tactical Black or Military | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device. | Class II | Terminated | |
| Z-0133-2015 | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain