Product code LOZ ยท Class 3
Artificial Heart
0510(k)s in 12 months (0 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in LOZ
| Company | 510(k)s | Recalls |
|---|---|---|
| SynCardia Systems Inc. | 0 | 4 |
| Abiomed, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2023 | SynCardia Systems LLC SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO Completed |
LOZ | None listed |
| Jan 27, 2023 | SynCardia Systems LLC SynCardia Total Artificial Heart System (70CC): 500101-001
SynCardia Total Artificial Heart System (50CC): 570500-000 Open, Classified |
LOZ | None listed |
| Oct 21, 2016 | SynCardia Systems Inc. 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 Terminated |
LOZ | None listed |
| Sep 17, 2015 | SynCardia Systems Inc. Temporary Total Artificial Heart (TAH-t) with Freedom Driver System
REF 595000-001
Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, wh Terminated |
LOZ | None listed |
| Sep 20, 2008 | Abiomed, Inc. Abiomed : Abiocor Implantable Heart Replacement Kit System
Catalog Number:: 0034-8401-HD
The product is intended to be implanted in the thoracic cavity and replaces operation and function of the nativ Terminated |
LOZ | None listed |
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