Company
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Medline Prefilled 550 ml Sterile Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 5ml Normal Saline (0.9%) Unit Dose Terminated |
CAF | K820227 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex Unit Dose 15 ml Normal Saline Terminated |
CAF | K820227 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex Unit Dose 5 ml Normal Saline (0.9%) Terminated |
CAF | K820227 |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Medline Prefilled 350 ml Sterile Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 550 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 500 ml Sterile Water USP Pour Bottle Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 1000 ml Sterile Water USP Pour Bottle Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 550 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Feb 4, 2019 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Portex 350 ml Sterile Water Humidifier w/5psi Adapt. Terminated |
CAF | None listed |
| Sep 5, 2017 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 Terminated |
FQH | K080779 |