EKOS
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Boston ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
- 510(k) clearances: 25
- Device recalls: 6
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Aug 17, 2020 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)K200648 · QEY | 510(k) clearances |
| Aug 22, 2016 | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic ConClass II · Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels l | Device recalls |
| Aug 9, 2016 | EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterClass II · The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices | Device recalls |
| Jan 21, 2016 | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device wClass II · The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDD | Device recalls |
| Jun 24, 2015 | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular DevClass II · The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. | Device recalls |
| Oct 2, 2013 | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilClass II · The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC fi | Device recalls |
| May 24, 2012 | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-561Class II · EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelli | Device recalls |
| Aug 3, 2011 | EKOSONIC ENDOVASCULAR SYSTEMK111705 · QEY | 510(k) clearances |
| Jun 26, 2008 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATIONK081467 · QEY | 510(k) clearances |
| Apr 30, 2008 | EndoWave Infusion SystemK080392 · QEY | 510(k) clearances |
| Apr 22, 2008 | ENDOWAVE INFUSION SYSTEMK073166 · KRA | 510(k) clearances |
| Oct 4, 2007 | ENDOWAVE INFUSION SYSTEMK072507 · QEY | 510(k) clearances |
| Aug 10, 2007 | ENDOWAVE INFUSION SYSTEMK071933 · QEY | 510(k) clearances |
| Aug 6, 2007 | EKOS MICRO-INFUSION SYSTEMK063620 · QEY | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- bostonscientific.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built