EKOS Corporation
EKOS Corporation appears in FDA public data with 6 recalls, 2 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2890-2016, Class II) was initiated on August 22, 2016. Its most recent 510(k) clearance was granted on August 17, 2020.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 2
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2890-2016 | Class II | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart use | August 22, 2016 |
| Z-2854-2016 | Class II | EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter | August 9, 2016 |
| Z-0864-2016 | Class II | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a s | January 21, 2016 |
| Z-2148-2015 | Class II | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device | June 24, 2015 |
| Z-0133-2014 | Class II | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average p | October 2, 2013 |
| Z-2023-2012 | Class II | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; | May 24, 2012 |