Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled 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 13, 2026, FDA's public records list RanD with 4 510(k) clearances and 2 device recalls. The most recent is a device recall dated Apr 30, 2021: Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120.
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.
| Date | Record | Source |
|---|---|---|
| Apr 30, 2021 | Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120Class II · The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a c | Device recalls |
| Apr 30, 2021 | Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominalClass II · The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a c | Device recalls |
| Dec 28, 2016 | Hang&Go PACK161613 · LGZ | 510(k) clearances |
| May 8, 2012 | PERFORMER HT/ HANG&GO HT BASICK120026 · LGZ | 510(k) clearances |
| Mar 21, 2007 | PERFORMER CBP SYSTEMK070213 · DTQ | 510(k) clearances |
| Mar 15, 2006 | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPBK052555 · DTQ | 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
