Data / Medical devices / Germany / Dornier Medtech GMBH
Dornier Medtech GMBH: FDA-registered device maker in WESSLING Bavaria, Germany, 23 510(k) clearances and 1 PMA approval
Dornier Medtech GMBH is registered with the FDA (registration 9611388) in WESSLING Bavaria, Germany. It lists 4 device types. The FDA files 23 510(k) clearances and 1 PMA approval under its listings, the newest dated February 22, 2023. 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
- 9611388
- FEI number
- 3002806833
- Address
- Argelsrieder Feld 7, WESSLING Bavaria, Germany, D-82234
- Owner or operator
- DORNIER MEDTECH GMBH (8010622)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- December 17, 1986
- Registered through
- 2026
- Brand names listed
- Compact Alpha Lithotripter, Compact Delta Lithotripter, Compact Sigma Lithotripter, DORNIER UROTRACT 1, Delta III Lithotripter, Diode Family of Lasers, Dornier Medilas D FlexiPulse, Dornier Medilas D Litebeam and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Complaint file establishment | accessdata.fda.gov |
| Table, Cystometric, Non-Electric And Accessories | KQS | 1 | 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 |
|---|---|---|---|---|---|---|
| February 22, 2023 | K221903 | Delta III Pro | LNS | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| July 27, 2022 | K213252 | Dornier Thulio | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| March 7, 2018 | K180350 | Dornier Medilas H Solvo 35 Laser | GEX | Substantially Equivalent | Dornier Medtech America | accessdata.fda.gov |
| August 8, 2017 | K172084 | Delta III Lithotripter | LNS | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| July 30, 2015 | K151298 | Gemini XXP-HP | LNS | Substantially Equivalent | Dornier Medtech America | accessdata.fda.gov |
| June 30, 2015 | K151485 | GENESIS | JAA | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| November 26, 2014 | K133434 | GENESIS II | JAA | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| September 23, 2013 | K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | LNS | Substantially Equivalent | Dornier Medtech America | accessdata.fda.gov |
| May 14, 2013 | K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | LNS | Substantially Equivalent | Dornier Medtech Systems | accessdata.fda.gov |
| March 21, 2013 | K130344 | DORNIER MEDILAS UROPULSE | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| February 1, 2013 | K122159 | DORNIER MEDILAS H30 SOLVO | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| January 18, 2013 | K122768 | GENESIS | JAA | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| September 24, 2012 | K121656 | GEMINI LITHOTRIPTER | LNS | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| December 7, 2011 | K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| February 12, 2009 | K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| June 27, 2008 | K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| May 21, 2007 | K070536 | MEDILAS D FAMILY LASERS | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061455 | DORNIER MEDILAS H 20 LASER | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| August 19, 2002 | K021724 | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS | GEX | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| April 17, 2001 | K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER | LNS | Substantially Equivalent | Dornier Medtech America, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991183 | DORNIER LASERTRODE FIBER | GEX | Substantially Equivalent | Dornier Surgical Products, Inc. | accessdata.fda.gov |
| July 17, 1998 | K981718 | DORNIER MEDILAS H | GEX | Substantially Equivalent | Dornier Surgical Products, Inc. | accessdata.fda.gov |
| December 6, 1995 | K955019 | UROTRACT I | KQS | Substantially Equivalent | Dornier Medtech America, Inc. | 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 |
|---|---|---|---|---|---|---|
| December 19, 1984 | P840008 | DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) | LNS | 63 | September 2, 1999 | accessdata.fda.gov |
Compare with other makers
- All makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Powered Laser Surgical Instrument
- All makers of Table, Cystometric, Non-Electric And Accessories
Updated February 22, 2023. 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.