Home › Device types › FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FDA product code FAP · Class 2 · Gastroenterology, Urology
29
Registered devices
55
Adverse events
6
Recalls
85
510(k) clearances
Devices with this code
Cook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDUrethral Catheter Electrode — SPES MEDICA SPAUrethral Catheter Electrode — SPES MEDICA SPACook — COOK INCORPORATEDCook — COOK INCORPORATEDSilber — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDDewan — COOK INCORPORATEDUrethral Catheter Electrode — SPES MEDICA SPACook — COOK INCORPORATEDUrethral Catheter Electrode — SPES MEDICA SPACook — COOK INCORPORATEDMadduri — COOK INCORPORATEDCook — COOK INCORPORATEDRUSCH — TELEFLEX INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDUrethral Catheter Electrode — SPES MEDICA SPASpes Medica Pudendal Electrode — SPES MEDICA SPA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-08 | Spes Medica | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| 2021-04-08 | Spes Medica | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex |
| 2005-12-13 | Sandhill Scientific, Inc | The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- f |
| 2005-12-13 | Sandhill Scientific, Inc | The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- f |
| 2005-12-13 | Sandhill Scientific, Inc | Labeling does not indicate that the product contains latex. |
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