Data / Medical devices / Germany / Oehm Und Rehbein GMBH
Oehm Und Rehbein GMBH: FDA-registered device maker in ROSTOCK Mecklenburg-Western Pomerania, Germany, 5 510(k) clearances
Oehm Und Rehbein GMBH is registered with the FDA (registration 3006542593) in ROSTOCK Mecklenburg-Western Pomerania, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 24, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006542593
- Address
- Neptunallee 7 c, ROSTOCK Mecklenburg-Western Pomerania, Germany, 18057
- Owner or operator
- OEHM UND REHBEIN GMBH (9098601)
- Roles
- Manufacturer
- First device listed
- June 5, 2007
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 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 |
|---|---|---|---|---|---|---|
| September 24, 2018 | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | IZL | Substantially Equivalent | Oehm Und Rehbein GmbH | accessdata.fda.gov |
| August 29, 2014 | K141440 | DICOMPACS DX-R WITH FLAT PANEL | MQB | Substantially Equivalent | Oehm Und Rehbein GmbH | accessdata.fda.gov |
| November 5, 2013 | K131211 | DICOMPACS DX-R WITH FLAT PANEL | MQB | Substantially Equivalent | Oehm Und Rehbein GmbH | accessdata.fda.gov |
| December 11, 2009 | K091364 | DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 | LLZ | Substantially Equivalent | Oehm Und Rehbein GmbH | accessdata.fda.gov |
| April 25, 2007 | K070618 | DICOMPACS, MODEL 5 | LLZ | Substantially Equivalent | Oehm Und Rehbein GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Mobile
- All makers of System, Image Processing, Radiological
Updated September 24, 2018. 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.