Aesculap-Meditec North America: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aesculap-Meditec North America” (first 1998, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under B. Braun, based on public ownership records.
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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
Most recent Aesculap-Meditec North America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994116 | LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) | GEX | 2000-06-01 | 178 |
| K992707 | MCL 29 DERMABLATE ER:YAG LASER SYSTEM | GEX | 1999-10-19 | 69 |
| K991285 | LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE | GEX | 1999-07-12 | 88 |
| K981196 | MEDITEC LINK | HQF | 1998-06-17 | 90 |
| K980361 | DERMABLATE ER: YAG LASER SYSTEM | GEX | 1998-04-21 | 82 |
| K974467 | AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 | HJO | 1998-02-19 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Aesculap-Meditec North America.
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.
- Aesculap-Meditec GmbH (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aesculap-Meditec North America?
FDA lists 6 510(k) clearances under the applicant name “Aesculap-Meditec North America” (first 1998, latest 2000), 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 Aesculap-Meditec North America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aesculap-Meditec North America is 86 days.
Which FDA product codes appear under Aesculap-Meditec North America?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 1); HQF (Laser, Ophthalmic, 1).
Next steps
- See all 6 Aesculap-Meditec North America clearances with predicates and recalls
- Run predicate analysis for product code GEX, Aesculap-Meditec North America'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.