Home › Semler Technologies, Inc. › ArmBoard - Flat
ArmBoard - Flat
Semler Technologies, Inc. · Model 8100-F · UDI-DI 10815614020682
FMQ
Prescription
10
510(k) clearances
1,029
Adverse events (221 deaths)
33
Recalls
109
Facilities
Description
The Flat ArmBoard Model 8100-F slides under a patient mattress and integrates with the single-use mBrace Model 4250 wrist support device to support a patient's arm during a cannulation procedure such as a catheterization into the radial artery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-15 | DeRoyal Industries Inc | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. |
| 2021-08-18 | Queen Comfort Products lLC | Marketed without FDA clearance |
| 2020-02-27 | DeRoyal Industries Inc | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. |
| 2019-04-12 | TIDI PRODUCTS | Not meeting design specifications. |
| 2015-08-19 | Med Tec Inc | The wrist straps used for positioning the patient are too long |
| 2014-12-11 | Med Tec Inc | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. |
| 2014-12-11 | Med Tec Inc | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. |
| 2014-02-21 | DeRoyal Industries Inc | Moldy smell in product |
| 2012-10-31 | J T Posey Company | The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow th |
| 2009-04-20 | J T Posey Company | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's m |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.