Data / Medical devices / United States / Zurich Medical Inc
Zurich Medical Inc: FDA-registered device maker in Plymouth, MN, United States, 1 510(k) clearance
Zurich Medical Inc is registered with the FDA (registration 3013943846) in Plymouth, MN, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013943846
- Address
- 2405 Xenium Ln N, Plymouth, MN, United States, 55441
- Owner or operator
- Zurich Medical Inc (10060697)
- Roles
- Manufacturer
- First device listed
- February 27, 2020
- Registered through
- 2026
- Brand names listed
- Zurich Face Shield, Zurich Medical Accessory Cable, Zurich Pressure Guidewire System Model 100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | 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 |
|---|---|---|---|---|---|---|
| August 14, 2019 | K190852 | Zurich Pressure Guidewire System Model 100 | DXO | Substantially Equivalent | Zurich Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Computer, Diagnostic, Programmable
- All makers of Wire, Guide, Catheter
- All makers of Computer, Blood-Pressure
- All makers of Accessory, Surgical Apparel
Updated August 14, 2019. 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.