Heraeus Medical GmbH: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Heraeus Medical GmbH” (first 2014, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Since 2017 the median was 77 days, against 86 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 30 |
| 2015 | 1 | 148 |
| 2016 | 1 | 116 |
| 2017 | 0 | — |
| 2018 | 1 | 27 |
| 2019 | 2 | 132 |
| 2020 | 1 | 87 |
| 2021 | 1 | 130 |
| 2022 | 2 | 43 |
| 2023 | 1 | 165 |
| 2024 | 2 | 117 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Heraeus Medical GmbH took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOD | Bone Cement | 9 | 9 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Heraeus Medical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241674 | OSTEOPAL® V | LOD | 2024-12-05 | 177 |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | KWL | 2024-02-15 | 57 |
| K222570 | COPAL knee moulds | JWH | 2023-02-04 | 165 |
| K220492 | COPAL exchange G hip spacer | KWY | 2022-03-23 | 29 |
| K213812 | PALACOS MV pro | LOD | 2022-02-02 | 57 |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | LOD | 2021-07-09 | 130 |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | LOD | 2020-11-23 | 87 |
| K191016 | COPAL exchange G Hip and Knee Spacers | KWY | 2019-11-01 | 198 |
| K190766 | PALACOS fast R+G | LOD | 2019-05-31 | 67 |
| K182260 | PALACOS MV | LOD | 2018-09-17 | 27 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Heraeus Medical GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Heraeus Kulzer, Inc. (166 510(k)s)
- Heraeus Lasersonics, Inc. (38 510(k)s)
- Heraeus Surgical, Inc. (8 510(k)s)
- Heraeus Kulzer GmbH & Co. KG (4 510(k)s)
- Heraeus Medical Components, LLC (4 510(k)s)
- Heraeus Dental Gold Corp. (3 510(k)s)
- Heraeus Med GmbH (3 510(k)s)
- Heraeus, Inc. (1 510(k)s)
- Heraeus Instruments GmbH (1 510(k)s)
- Heraeus Kulzer, Inc., Dental Products Division (1 510(k)s)
- Heraeus Kulzer, LLC (Mitsui Chemicals Group) (1 510(k)s)
- Heraeus Kulzer, LLC, Mitsui Chemicals Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heraeus Medical GmbH?
FDA lists 13 510(k) clearances under the applicant name “Heraeus Medical GmbH” (first 2014, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heraeus Medical GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heraeus Medical GmbH is 87 days. Since 2017: 77 days, versus 86 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Heraeus Medical GmbH?
The most frequent FDA product codes under this applicant name are LOD (Bone Cement, 9); KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, 2); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 1).
Next steps
- See all 13 Heraeus Medical GmbH clearances with predicates and recalls
- Run predicate analysis for product code LOD, Heraeus Medical GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.