Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-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 NewDeal SA with 10 510(k) clearances and 5 device recalls. The most recent is a device recall dated May 22, 2018: TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S….
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.
| May 22, 2018 | TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150Class II · Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection | Device recalls |
| May 22, 2018 | UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430SClass II · Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection | Device recalls |
| May 22, 2018 | ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023SClass II · Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection | Device recalls |
| May 22, 2018 | Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 11Class II · Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection | Device recalls |
| May 22, 2018 | ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004SClass II · Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection | Device recalls |
| Mar 20, 2012 | NEWDEAL INTERPHALANGEAL IMPLANTK103623 · HTY | 510(k) clearances |
| Apr 14, 2011 | NEWDEAL COMPRESSION PLATESK093914 · HRS | 510(k) clearances |
| Jan 22, 2010 | MODIFIED: NEWDEAL HALLU PLATESK093781 · HRS | 510(k) clearances |
| Jul 29, 2009 | PANTA NAIL (DIA. 10MM), PANTA NAIL XLK091788 · HSB | 510(k) clearances |
| Jul 10, 2009 | NEWDEAL HALLU LOCK PLATE SYSTEMK083154 · HRS | 510(k) clearances |
| Jun 30, 2009 | NEWDEAL COMPRESSION PLATEK091609 · HRS | 510(k) clearances |
| Feb 21, 2008 | NEWDEAL TIBIAXYS SYSTEMK073375 · HRS | 510(k) clearances |
| Jul 9, 2007 | QWIX POSITIONING SCREWK071639 · HWC | 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
