Storz Ophthalmics, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Storz Ophthalmics, Inc.” (first 1988, latest 1995), plus 2 PMA decisions, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| HQL | Intraocular Lens | 2 | 0 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HQX | Implant, Orbital, Extra-Ocular | 1 | 1 |
Review panels
Most recent Storz Ophthalmics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | HQX | 1995-03-02 | 21 |
| K884060 | MEDITEC QL-15 ND:YAG LASER | GEX | 1988-11-04 | 39 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800027 | PMA | BINKHORST & FEDOROV I IRIS CLIP IOLS | 1982-07-26 |
| P800017 | PMA | CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS | 1981-12-01 |
Recalls
openFDA lists no recalls under a recalling firm named Storz Ophthalmics, Inc..
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.
- Storz Instrument Co. (101 510(k)s)
- Storz (6 510(k)s)
- Storz Medical AG (3 510(k)s)
- Storz AM Mark GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Storz Ophthalmics, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Storz Ophthalmics, Inc.” (first 1988, latest 1995), plus 2 PMA decisions, 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 Storz Ophthalmics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Storz Ophthalmics, Inc. is 30 days.
Which FDA product codes appear under Storz Ophthalmics, Inc.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 2); GEX (Powered Laser Surgical Instrument, 1); HQX (Implant, Orbital, Extra-Ocular, 1).
Next steps
- See all 2 Storz Ophthalmics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Storz Ophthalmics, Inc.'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.