Home › PENTAX OF AMERICA, INC. › N/A
N/A
PENTAX OF AMERICA, INC. · Model 7182-2300 · UDI-DI 04961333242016
KLA
Prescription
1
510(k) clearances
7
Adverse events
1
Recalls
15
Facilities
Description
MANOMETER CABLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-04-06 | Medtronic Gastroenterology / Urology | Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration 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.