Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list DePuy Ireland with 50 510(k) clearances, 1 device recall and 1 AI-enabled device. The most recent is a 510(k) clearance dated Jun 25, 2026: VELYS™ Robotic-Assisted Solution.
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.
| Jun 25, 2026 | VELYS™ Robotic-Assisted SolutionK260480 · OLO | 510(k) clearances |
| Jun 25, 2026 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemK261458 · JWH | 510(k) clearances |
| May 15, 2026 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementK260536 · KWL | 510(k) clearances |
| Mar 11, 2026 | INHANCE™ Reverse Shoulder SystemK253624 · PHX | 510(k) clearances |
| Mar 6, 2026 | VELYS™ Hip NavigationK253551 · QIH | 510(k) clearances |
| Mar 6, 2026 | VELYS Hip NavigationK253551 · Radiology | AI-enabled devices |
| Nov 19, 2025 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsK253197 · JWH | 510(k) clearances |
| May 23, 2025 | RECLAIM Monobloc Revision Femoral StemK251292 · LZO | 510(k) clearances |
| Jan 22, 2025 | EMPHASYS Acetabular SystemK243977 · LPH | 510(k) clearances |
| Dec 19, 2022 | BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size Class II · All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endoto | Device recalls |
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
