Company
Flowonix Medical Inc
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)
13recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | 13 |
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) |
|---|---|---|---|
| May 26, 2021 | Flowonix Medical Inc Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following:
Prometra Programmable Infusion Pump System:
MODEL/CATALOG #(s):
Catalog No. US Model Terminated |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific) Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific) Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082 Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242 Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228 Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082 Open, Classified |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Terminated |
LKK | None listed |
| Jun 19, 2017 | Flowonix Medical, Inc. PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling Terminated |
LKK | None listed |