Heraeus Medical GmbH
WEHRHEIM Hesse, DE
Heraeus Medical GmbH appears in FDA device records in WEHRHEIM Hesse, DE. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Heraeus Medical GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Heraeus Medical GmbH (Dental Division)enforcement report, recall
510(k) clearance history
FDA records hold 13 510(k) clearances for Heraeus Medical GmbH between 2014 and 2024. The busiest year on record is 2019, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241674 | OSTEOPAL® V | LOD | Substantially Equivalent | |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | KWL | Substantially Equivalent | |
| K222570 | COPAL knee moulds | JWH | Substantially Equivalent | |
| K220492 | COPAL exchange G hip spacer | KWY | Substantially Equivalent | |
| K213812 | PALACOS MV pro | LOD | Substantially Equivalent | |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | LOD | Substantially Equivalent | |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | LOD | Substantially Equivalent | |
| K191016 | COPAL exchange G Hip and Knee Spacers | KWY | Substantially Equivalent | |
| K190766 | PALACOS fast R+G | LOD | Substantially Equivalent | |
| K182260 | PALACOS MV | LOD | Substantially Equivalent | |
| K153737 | OSTEOPAL plus | LOD | Substantially Equivalent | |
| K150119 | PALACOS R pro | LOD | Substantially Equivalent | |
| K142157 | PALACOS R+G PRO | LOD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006406161 | 3006406161 | Heraeus Medical GmbH | PHILIPP-REIS-STRASSE 8/13, WEHRHEIM Hesse D-61273 DE | 2026 | |
| 3013186738 | 3013186738 | Heraeus Medical LLC | Township Line Road 770, Suite 300, Yardley, PA 19067 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LODBone Cement
- MBBBone Cement, Antibiotic
- NDNCement, Bone, Vertebroplasty
- KIHDispenser, Cement
- JDYEvacuator, Vapor, Cement Monomer
- JDZMixer, Cement, For Clinical Use
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWTTemplate
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1998-2026 | Heraeus, PALAMIX duo. Material Number: 66057897. | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months). | Class III | Open, Classified | |
| Z-1997-2026 | Heraeus, PALAMIX uno. Material Number: 66057893. | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months). | Class III | Open, Classified | |
| Z-1083-2026 | Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed. | Class II | Open, Classified | |
| Z-1082-2026 | Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed. | Class II | Open, Classified | |
| Z-1081-2026 | Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed. | Class II | Open, Classified | |
| Z-1080-2026 | Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A | increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain