← Every applicant
DePuy Ireland UC FDA Approvals
0 new drug approvals and 43 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| ATTUNE Total Knee System; ATTUNE Cementless Knee System510(k)Jun 25, 2026Orthopedic |
| VELYS Robotic-Assisted Solution510(k)Jun 25, 2026Neurology |
| Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement510(k)May 15, 2026Orthopedic |
| INHANCE Reverse Shoulder System510(k)Mar 11, 2026Orthopedic |
| VELYS Hip Navigation510(k)Mar 6, 2026Radiology |
| ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors510(k)Nov 19, 2025Orthopedic |
| RECLAIM Monobloc Revision Femoral Stem510(k)May 23, 2025Orthopedic |
| EMPHASYS Acetabular System510(k)Jan 22, 2025Orthopedic |
| INHANCE INTACT510(k)Dec 23, 2024Orthopedic |
| ATTUNE Revision Hinge Knee510(k)Nov 21, 2024Orthopedic |
| EMPHASYS Acetabular Shell with RapiTite HA510(k)Oct 7, 2024Orthopedic |
| ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;510(k)Jul 11, 2024Orthopedic |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology510(k)Jun 18, 2024Orthopedic |
| VELYS Robotic-Assisted Solution510(k)Jun 5, 2024Neurology |
| PINNACLETM Constrained Acetabular Liners510(k)Apr 4, 2024Orthopedic |
| ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System510(k)Mar 21, 2024Orthopedic |
| EMPHASYS Dual Mobility System510(k)Feb 15, 2024Orthopedic |
| DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional510(k)Jan 19, 2024Orthopedic |
| CORAIL Cemented Femoral Stem510(k)Dec 19, 2023Orthopedic |
| VELYS Robotic-Assisted Solution510(k)Dec 14, 2023Neurology |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology510(k)Dec 11, 2023Orthopedic |
| INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid510(k)Nov 13, 2023Orthopedic |
| EMPHASYS Femoral Stems510(k)Oct 11, 2023Orthopedic |
| DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System510(k)Sep 20, 2023Orthopedic |
| INHANCE Shoulder System, Sterile Single Use Instrumentation510(k)Jul 21, 2023Orthopedic |
| ATTUNE® Revision Cones510(k)Mar 10, 2023Orthopedic |
| ARTICUL/EZE Ceramic Heads510(k)Jan 6, 2023Orthopedic |
| INHANCETM Shoulder System Humeral Stems and Stemless510(k)Dec 2, 2022Orthopedic |
| DePuy Reclaim Monobloc Revision Femoral Stem510(k)Oct 21, 2022Orthopedic |
| ATTUNE Revision Cones510(k)Oct 17, 2022Orthopedic |
| EMPHASYS Acetabular System510(k)Sep 6, 2022Orthopedic |
| INHANCETM Reverse Glenoid Peripheral Posts510(k)Aug 31, 2022Orthopedic |
| C-Stem AMT LE Prosthesis510(k)Jul 22, 2022Orthopedic |
| INHANCETM Hybrid Anatomic Glenoid Implant510(k)Jun 8, 2022Orthopedic |
| INHANCE Reverse Shoulder System510(k)Apr 21, 2022Orthopedic |
| ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP510(k)Jan 18, 2022Orthopedic |
| GLOBAL UNITE Platform Shoulder System510(k)Sep 15, 2021Orthopedic |
| ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert510(k)Aug 25, 2021Orthopedic |
| EMPHASYS Femoral Stems510(k)Aug 5, 2021Orthopedic |
| DELTA XTEND Reverse Shoulder System510(k)Jul 22, 2021Orthopedic |
| Actis DuoFix Hip Prosthesis- Collarless510(k)May 20, 2021Orthopedic |
| BI-MENTUM ALTRX® Dual Mobility Liner510(k)Apr 28, 2021Orthopedic |
| VELYS Robotic-Assisted Solution510(k)Jan 14, 2021Neurology |