Home › Device types › KOE
Dilator, Urethral
FDA product code KOE · Class 2 · Gastroenterology, Urology
388
Registered devices
221
Adverse events
3
Recalls
27
510(k) clearances
Devices with this code
UroMax Ultra Kit — BOSTON SCIENTIFIC CORPORATIONV. Mueller — STERIS CORPORATIONCook — COOK INCORPORATEDPeel-Away — COOK INCORPORATEDAmplatz — COOK INCORPORATEDUroMax Ultra — BOSTON SCIENTIFIC CORPORATIONAmplatz — COOK INCORPORATEDUroMax Ultra — BOSTON SCIENTIFIC CORPORATIONEZDilate — Gyrus ACMI, LLCAce Medical Company — Ebner Medical, LLCCook — COOK INCORPORATEDUroMax Ultra Kit — BOSTON SCIENTIFIC CORPORATIONAmplatz — COOK INCORPORATEDAmplatz — COOK INCORPORATEDCook — COOK INCORPORATEDPeel-Away — COOK INCORPORATEDFlexor — COOK INCORPORATEDEZDilate — Gyrus ACMI, LLCCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDAmplatz — COOK INCORPORATEDCook — COOK INCORPORATED
Recent 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 |
| 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 |
| 2005-08-01 | Cook Urological, Inc. | Mislabeled as to size. |
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