Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of HeraeusLabelled 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 15, 2026, FDA's public records list Heraeus Medical GmbH with 13 510(k) clearances and 10 device recalls. The most recent is a device recall dated Aug 20, 2026: PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Rad….
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.
| Aug 20, 2026 | PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) boneClass II · Potential for monomer liquid leakage. | Device recalls |
| Aug 20, 2026 | PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone ceClass II · Potential for monomer liquid leakage. | Device recalls |
| Aug 20, 2026 | PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone Class II · Potential for monomer liquid leakage. | Device recalls |
| Aug 20, 2026 | PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cemClass II · Potential for monomer liquid leakage. | Device recalls |
| Mar 25, 2026 | Heraeus, PALAMIX uno. Material Number: 66057893.Class III · Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod ma | Device recalls |
| Mar 25, 2026 | Heraeus, PALAMIX duo. Material Number: 66057897.Class III · Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod ma | Device recalls |
| Dec 9, 2025 | Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A PrClass II · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation re | Device recalls |
| Dec 9, 2025 | Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A ProdClass II · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation re | Device recalls |
| Dec 5, 2024 | OSTEOPAL® VK241674 · LOD | 510(k) clearances |
| Feb 15, 2024 | COPAL® exchange G hip spacer; COPAL® G+VK234028 · KWL | 510(k) clearances |
| Feb 4, 2023 | COPAL knee mouldsK222570 · JWH | 510(k) clearances |
| Mar 23, 2022 | COPAL exchange G hip spacerK220492 · KWY | 510(k) clearances |
| Feb 2, 2022 | PALACOS MV proK213812 · LOD | 510(k) clearances |
| Jul 9, 2021 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proK210607 · LOD | 510(k) clearances |
| Nov 23, 2020 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GK202475 · LOD | 510(k) clearances |
| Nov 1, 2019 | COPAL exchange G Hip and Knee SpacersK191016 · KWY | 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
