Data / Medical devices / Germany / OSYPKA GmbH
OSYPKA GmbH: FDA-registered device maker in Rheinfelden Baden-Wurttemberg, Germany, 1 510(k) clearance and 1 PMA approval
OSYPKA GmbH is registered with the FDA (registration 3003923762) in Rheinfelden Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated January 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003923762
- Address
- Earl-H.-Wood-Str. 1, Rheinfelden Baden-Wurttemberg, Germany, 79618
- Owner or operator
- Osypka GmbH (10048738)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- August 21, 2022
- Registered through
- 2026
- Brand names listed
- MAGiC Magnetic Interventional Ablation Catheter, OSYPKA TME pacing wires, RIWO D-URS, Revi Implant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Implanted Tibial Electrical Urinary Continence Device | QXM | 2 | Contract manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 26, 2024 | K232261 | TME Temporary Myocardial Electrode | LDF | Substantially Equivalent | Osypka AG | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 5, 2026 | P240014 | MAGiC Ablation Catheter | LPB | 1 | July 31, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Pacemaker, Temporary
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Cardiac Ablation Percutaneous Catheter
- All makers of Implanted Tibial Electrical Urinary Continence Device
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.