Monitor, Ultrasonic, Nonfetal
Regulation 892.1540
0510(k)s in 12 months (38 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in JAF
| Company | 510(k)s | Recalls |
|---|---|---|
| Natus Neurology Inc | 0 | 4 |
| Unetixs Vascular, Inc. | 0 | 4 |
| Imex Medical Systems, Inc. | 3 | 0 |
| Thd Spa | 3 | 0 |
| Biomedix, Inc. | 2 | 0 |
| Kt Medical, Inc. | 2 | 0 |
| L&M Ultrascope Life Monitoring Sys. | 2 | 0 |
| Medasonics, Inc. | 2 | 0 |
| Nicolet Biomedical | 2 | 0 |
| Philips Medical Systems, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01 Open, Classified |
JAF | K904392 |
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 Open, Classified |
JAF | K904392 |
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01 Open, Classified |
JAF | K904392 |
| Mar 1, 2023 | Unetixs Vascular, Inc. MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01 Open, Classified |
JAF | K904392 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. Terminated |
JAF | K982635 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. Terminated |
JAF | K982635 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, et Terminated |
JAF | K982635 |
| Jun 9, 2017 | Natus Neurology Inc Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surg Terminated |
JAF | K982635 |
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