Data / Medical devices / Germany / Moeller Medical GMBH
Moeller Medical GMBH: FDA-registered device maker in FULDA Hesse, Germany, 4 510(k) clearances
Moeller Medical GMBH is registered with the FDA (registration 3006611221) in FULDA Hesse, Germany. It lists 14 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 19, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006611221
- FEI number
- 3002807634
- Address
- Wasserkuppenstrasse 29-31, FULDA Hesse, Germany, 36043
- Owner or operator
- Geckeler (9080465)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 17, 2007
- Registered through
- 2026
- Brand names listed
- Basket Cannula 1.5, Basket Cannula 2, Biopsy Kit 03.702.222S, Biopsy Kit 03.702.223S, Bone Biopsy Cannula BOY-1080-XX-XXXX, Bone Marrow Aspiration Biopsy BOW-1070-XX-XXXX, Bone Marrow Aspiration Biopsy BOW-1076-XX-XXXX, Bone Marrow Biopsy System BOW-1060-XX-XXXX and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 19, 2017 | K162588 | Möller Medical Biopsy Needles and Systems | KNW | Substantially Equivalent | Moller Medical GmbH | accessdata.fda.gov |
| December 18, 2015 | K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | JXG | Substantially Equivalent | Moller Medical GmbH | accessdata.fda.gov |
| December 13, 2013 | K121248 | LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC | JXG | Substantially Equivalent | Moller Medical GmbH | accessdata.fda.gov |
| August 25, 2006 | K053451 | LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); | QPB | Substantially Equivalent | Moeller Medical GmbH & Co. KG | accessdata.fda.gov |
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Updated June 19, 2017. 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.