Home › Gyrus ACMI, LLC › EZDilate
EZDilate
Gyrus ACMI, LLC · Model BURS0510K · UDI-DI 00821925033115
KOE
Prescription
1
510(k) clearances
222
Adverse events
3
Recalls
65
Facilities
Description
Uro-EZDilate KIT 15Fr (5mm) X 10cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-04 | Cook Inc. | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| 2019-01-04 | Cook Inc. | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| 2005-08-01 | Cook Urological, Inc. | Mislabeled as to size. |
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.