Geister Medizin Technik GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Geister Medizin Technik GmbH” (first 1994, latest 2025), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 224 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 | 1 | 174 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 267 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Geister Medizin Technik GmbH took a median 220 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HAE | Rongeur, Manual | 1 | 1 |
| MGZ | Valvulotome | 1 | 1 |
Review panels
Most recent Geister Medizin Technik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242759 | Geister K-Rex rongeurs | HAE | 2025-06-06 | 267 |
| K180610 | Geister retractor for neuro - and spine surgery | GZT | 2018-08-29 | 174 |
| K022823 | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | MGZ | 2004-07-01 | 675 |
| K030788 | KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS | DWP | 2003-07-12 | 122 |
| K982365 | ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT | DXC | 1999-04-08 | 275 |
| K933699 | GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS | GEI | 1994-01-27 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Geister Medizin Technik 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Geister Medizin Technik GmbH?
FDA lists 6 510(k) clearances under the applicant name “Geister Medizin Technik GmbH” (first 1994, latest 2025), across 6 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 Geister Medizin Technik GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geister Medizin Technik GmbH is 224 days.
Which FDA product codes appear under Geister Medizin Technik GmbH?
The most frequent FDA product codes under this applicant name are DWP (Dilator, Vessel, Surgical, 1); DXC (Clamp, Vascular, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 6 Geister Medizin Technik GmbH clearances with predicates and recalls
- Run predicate analysis for product code DWP, Geister Medizin Technik 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.