Data / Medical devices / Switzerland / New Medical Technologies GMBH
New Medical Technologies GMBH: FDA-registered device maker in Bern, Switzerland, 1 510(k) clearance
New Medical Technologies GMBH is registered with the FDA (registration 3008252257) in Bern, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 2, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008252257
- Address
- Freiburgstrasse 453, Bern, Switzerland, 3018
- Owner or operator
- New Medical Technologies GmbH (10031563)
- Roles
- Manufacturer
- First device listed
- February 15, 2010
- Registered through
- 2026
- Brand names listed
- Cryosolutions
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | 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 |
|---|---|---|---|---|---|---|
| October 2, 2009 | K091721 | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 | GEH | Substantially Equivalent | New Medical Technologies GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2024 | 96067 | Class II | Ongoing | Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516 | During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use. | accessdata.fda.gov |
Compare with other makers
Updated February 5, 2025. 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.