Hager& Meisinger GmbH: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Hager& Meisinger GmbH” (first 2007, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 256 days. Since 2017 the median was 234 days, against 192 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 153 |
| 2014 | 3 | 356 |
| 2015 | 1 | 259 |
| 2016 | 1 | 306 |
| 2017 | 2 | 163 |
| 2018 | 2 | 162 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 521 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 258 |
| 2025 | 1 | 255 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hager& Meisinger GmbH took a median 234 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
| DZL | Screw, Fixation, Intraosseous | 5 | 5 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| EMG | Forceps, Tooth Extractor, Surgical | 1 | 1 |
Review panels
- Dental (14)
Most recent Hager& Meisinger GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | DZL | 2025-09-29 | 255 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | DZL | 2024-10-17 | 258 |
| K201210 | The Micro Screw System, Micro Screw System Basic | DZL | 2021-10-08 | 521 |
| K173819 | MyPlant II Implant System | DZE | 2018-08-09 | 234 |
| K180360 | OKTAGON Implant System | DZE | 2018-05-10 | 90 |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | DZE | 2017-05-24 | 114 |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | DZE | 2017-02-24 | 212 |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | NHA | 2016-11-21 | 306 |
| K143539 | Dental Implant OKTAGON Bone Level | DZE | 2015-08-31 | 259 |
| K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE | NHA | 2014-07-07 | 356 |
4 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-07-15.
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.
- Hager Worldwide, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hager& Meisinger GmbH?
FDA lists 14 510(k) clearances under the applicant name “Hager& Meisinger GmbH” (first 2007, latest 2025), 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 Hager& Meisinger GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hager& Meisinger GmbH is 256 days. Since 2017: 234 days, versus 192 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hager& Meisinger GmbH?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); DZL (Screw, Fixation, Intraosseous, 5); NHA (Abutment, Implant, Dental, Endosseous, 2).
Next steps
- See all 14 Hager& Meisinger GmbH clearances with predicates and recalls
- Run predicate analysis for product code DZE, Hager& Meisinger 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.