Home › ROI CPS, LLC › Regard™
Regard™
ROI CPS, LLC · Model GS00175M · UDI-DI 10194717106920
PXC
Prescription
0
510(k) clearances
1
Adverse events
1
Recalls
22
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
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.