Medical device makerLabelled 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 FX Solutions with 8 510(k) clearances and 2 device recalls. The most recent is a device recall dated Jun 4, 2018: Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designe….
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 |
|---|---|---|
| Jun 4, 2018 | Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatmeClass II · Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | Device recalls |
| Jun 4, 2018 | Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatmentClass II · Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. | Device recalls |
| May 17, 2017 | Humeris ShoulderK163669 · PHX | 510(k) clearances |
| Jan 17, 2017 | Humelock Reversed ShoulderK162455 · PHX | 510(k) clearances |
| Nov 13, 2015 | Humelock II Reversible Shoulder SystemK150488 · PHX | 510(k) clearances |
| Aug 27, 2015 | PRCT2K143721 · HRS | 510(k) clearances |
| Jul 28, 2014 | HUMELOCK II CEMENTED SHOULDER SYSTEMK140071 · KWT | 510(k) clearances |
| Nov 9, 2013 | HUMELOCK II CEMENTLESS SHOULDER SYSTEMK130759 · HSD | 510(k) clearances |
| Aug 13, 2013 | HUMELOCK II CEMENTED SHOULDER SYSTEMK123814 · KWT | 510(k) clearances |
| Nov 9, 2011 | HUMELOCK CEMENTED SHOULDER PROSTHESISK111097 · HSD | 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
