Mondeal Medical Systems GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mondeal Medical Systems GmbH” (first 2005, latest 2007), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 77 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Dental (3)
- Orthopedic (3)
Most recent Mondeal Medical Systems GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072740 | MONDEAL EXTREMITY BONE FIXATION SYSTEM | HRS | 2007-11-19 | 53 |
| K071798 | MONDEAL DISTAL RADIUS SYSTEM | HRS | 2007-09-17 | 77 |
| K071797 | MONDEAL HAND CONTOUR SYSTEM | HRS | 2007-09-17 | 77 |
| K062436 | SIS SINUS IMPLANT STABILIZER | JEY | 2007-07-30 | 343 |
| K050257 | LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) | DZE | 2005-02-07 | 4 |
| K042345 | LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) | DZE | 2005-01-13 | 136 |
Recalls
openFDA lists no recalls under a recalling firm named Mondeal Medical Systems 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.
- Mondeal North America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mondeal Medical Systems GmbH?
FDA lists 6 510(k) clearances under the applicant name “Mondeal Medical Systems GmbH” (first 2005, latest 2007), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mondeal Medical Systems GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mondeal Medical Systems GmbH is 77 days.
Which FDA product codes appear under Mondeal Medical Systems GmbH?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); DZE (Implant, Endosseous, Root-Form, 2); JEY (Plate, Bone, 1).
Next steps
- See all 6 Mondeal Medical Systems GmbH clearances with predicates and recalls
- Run predicate analysis for product code HRS, Mondeal Medical Systems 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.