Home › Barrier Technologies, LLC › SecureShield© Angiography 13" x 16" Scatter Reducing Drape
SecureShield© Angiography 13" x 16" Scatter Reducing Drape
Barrier Technologies, LLC · Model SS-5300 · UDI-DI 10860004894640
10
510(k) clearances
71
Adverse events
2
Recalls
193
Facilities
Description
Ultimate protection for femoral artery and radial access procedures. Unique shield design protects hands, face and body. Will not inhibit the physicians technique. The small fenestration and the slit to the shield edge provide maximum protection to hands and body and excellent maneuverability around the sheath.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-09 | GE Healthcare | GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not in |
| 2014-05-02 | GE Healthcare, LLC | GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is |
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.