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Acucise® Endopyelotomy System
APPLIED MEDICAL RESOURCES CORPORATION · Model B1005 · UDI-DI 00607915111663
10
510(k) clearances
392
Adverse events (2 deaths)
3
Recalls
39
Facilities
Description
Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIRE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-11 | Olympus Corporation of the Americas | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients |
| 2023-05-19 | Olympus Corporation of the Americas | Dilator tips may break in the package and in patients during surgical procedures. |
| 2011-04-15 | Gyrus Acmi, Incorporated | Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturin |
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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.