Storz Medical AG: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Storz Medical AG” (first 2018, latest 2021), plus 1 PMA decision, across 4 product codes in 3 review panels. Median 510(k) review time under this name: 133 days. Since 2017 the median was 133 days, against 133 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 |
|---|---|---|
| 2018 | 1 | 133 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 170 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Storz Medical AG took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| NBN | Generator, Shock-Wave, For Pain Relief | 1 | 0 |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 1 | 1 |
Review panels
Most recent Storz Medical AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | IPF | 2021-05-03 | 133 |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | PZL | 2021-02-21 | 206 |
| K173692 | D-Actor 200 Vibration Massage System | ISA | 2018-04-13 | 133 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080028 | PMA | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY | 2016-01-08 |
Recalls
openFDA lists no recalls under a recalling firm named Storz Medical AG.
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.
Device clinical trials
An industry sponsor named Storz Medical AG is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07272720: PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones (Recruiting, started 2025-12-11)
- NCT04333511: Brain Stimulation for Patients With Parkinson Disease (Completed, started 2019-12-02)
- NCT03770182: Brain Stimulation for Neurological Patients (Completed, started 2017-01-01)
- NCT04333329: Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD) (Completed, started 2015-08-08)
- NCT00720694: Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome (Completed, started 2006-06)
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 Ophthalmics, Inc. (2 510(k)s)
- Storz AM Mark GmbH (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Storz Medical AG?
FDA lists 3 510(k) clearances under the applicant name “Storz Medical AG” (first 2018, latest 2021), plus 1 PMA decision, across 4 product codes in 3 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 Medical AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Storz Medical AG is 133 days. Since 2017: 133 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Storz Medical AG?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 1); ISA (Massager, Therapeutic, Electric, 1); NBN (Generator, Shock-Wave, For Pain Relief, 1).
Next steps
- See all 3 Storz Medical AG clearances with predicates and recalls
- Run predicate analysis for product code IPF, Storz Medical AG'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.