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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Rex Medical with 21 510(k) clearances. The most recent is a 510(k) clearance dated Dec 15, 2021: Revolution Peripheral Atherectomy System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 15, 2021 | Revolution Peripheral Atherectomy SystemK212351 · MCW | 510(k) clearances |
| Sep 12, 2019 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireK191419 · MCW | 510(k) clearances |
| Jan 30, 2018 | Rex Medical Aspiration PumpK173389 · BTA | 510(k) clearances |
| Apr 16, 2015 | Option (TM) ELITE Vena Cava Filter 100cm SystemK143405 · DTK | 510(k) clearances |
| Nov 14, 2014 | CLEANER ROTATIONAL THROMBECTOMY SYSTEMK141617 · QEW | 510(k) clearances |
| Dec 17, 2013 | OPTION ELITE VENA CAVA FILTER SYSTEMK133243 · DTK | 510(k) clearances |
| Jun 1, 2012 | CLEANER ROTATIONAL THROMBECTOMY SYSTEMK120346 · MCW | 510(k) clearances |
| May 22, 2012 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICEK113103 · PNO | 510(k) clearances |
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
