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Data / Medical devices / Germany / Geister Medizintechnik GMBH

Geister Medizintechnik GMBH: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 8 510(k) clearances

Geister Medizintechnik GMBH is registered with the FDA (registration 8010697) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 49 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2027. 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.

Get makers like this oneWatch Geister Medizintechnik GMBH
FDA registration number
8010697
FEI number
3004053982
Address
Foehrenstr. 2, TUTTLINGEN Baden-Wurttemberg, Germany, D-78532
Owner or operator
GEISTER MEDIZINTECHN (8010697)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 27, 1983
Registered through
2027
Brand names listed
GEISTER® K-Rex™ rongeurs, Soft Tissue Retractor

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
Accessory Equipment, Cardiopulmonary BypassKRI1Manufactureraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Manufacturer, Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Manufactureraccessdata.fda.gov
ClampHXD1Contract manufacturer, Manufactureraccessdata.fda.gov
Clamp, UterineHGC1Manufactureraccessdata.fda.gov
Clamp, VascularDXC2Contract manufacturer, Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
Extractor, VeinNJZ1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Contract manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Manufactureraccessdata.fda.gov
Hemostat, SurgicalEMD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Cast Removal, Ac-PoweredLGH1Manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Contract manufacturer, Manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Contract manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufactureraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Manufactureraccessdata.fda.gov
Ring (Wound Protector), Drape Retention, InternalKGW2Specification developeraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
Rongeur, ManualHAE2Manufactureraccessdata.fda.gov
Saw, Electrically PoweredDWI1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Screwdriver, SurgicalLRZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Sizer, Heart-Valve, ProsthesisDTI1Manufactureraccessdata.fda.gov
Stabilizer, HeartMWS1Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
TrocarDRC2Manufacturer, Specification developeraccessdata.fda.gov
Twister, WireHXS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ValvulotomeMGZ2Contract manufacturer, Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 6, 2025K242759Geister K-Rex rongeursHAESubstantially EquivalentGeister Medizin Technik GmbHaccessdata.fda.gov
August 29, 2018K180610Geister retractor for neuro - and spine surgeryGZTSubstantially EquivalentGeister Medizin Technik GmbHaccessdata.fda.gov
July 5, 2013K123234ERMIS STERILIZATION CONTAINER SYSTEMKCTSubstantially EquivalentErmis Medizintechnikaccessdata.fda.gov
March 22, 2007K070509FISSO HOLDING SYSTEMGCJSubstantially EquivalentBaitella AGaccessdata.fda.gov
July 1, 2004K022823VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520MGZSubstantially EquivalentGeister Medizin Technik GmbHaccessdata.fda.gov
March 24, 2004K033644ENDOBOYGCJSubstantially EquivalentGeyser S.A.accessdata.fda.gov
July 12, 2003K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSDWPSubstantially EquivalentGeister Medizin Technik GmbHaccessdata.fda.gov
April 8, 1999K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXCSubstantially EquivalentGeister Medizin Technik GmbHaccessdata.fda.gov

Compare with other makers

Updated June 6, 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.