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Data / Medical devices / Germany / Geomed Medizin-Technik GMBH & Co. KG

Geomed Medizin-Technik GMBH & Co. KG: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 4 510(k) clearances

Geomed Medizin-Technik GMBH & Co. KG is registered with the FDA (registration 8010168) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 48 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 10, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Geomed Medizin-Technik GMBH & Co. KG
FDA registration number
8010168
FEI number
1000453845
Address
Ludwigstaler Strasse 27, TUTTLINGEN Baden-Wurttemberg, Germany, D-78532
Owner or operator
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG (8010168)
Roles
Contract manufacturer, Manufacturer
First device listed
March 28, 1978
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
ClampHXD1Contract manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Contract manufactureraccessdata.fda.gov
Clamp, VascularDXC2Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Contract manufactureraccessdata.fda.gov
Endoscope, NeurologicalGWG2Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Contract manufactureraccessdata.fda.gov
Forceps, EntKAE1Contract manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufactureraccessdata.fda.gov
Forceps, ObstetricalHDA2Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Contract manufactureraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Contract manufactureraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Contract manufactureraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Contract manufactureraccessdata.fda.gov
Forceps, Wire HoldingHYA1Contract manufactureraccessdata.fda.gov
HemostatHRQ1Contract manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Contract manufactureraccessdata.fda.gov
Inserter, Myringotomy TubeJYM1Contract manufactureraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Contract manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Contract manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Nipper, MalleusJYR1Contract manufactureraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Plier, OrthodonticJEX1Contract manufactureraccessdata.fda.gov
Punch, AdenoidKBS1Contract manufactureraccessdata.fda.gov
Punch, TonsilKBT1Contract manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Contract manufactureraccessdata.fda.gov
Retractor, EntKAL1Manufactureraccessdata.fda.gov
RongeurHTX1Contract manufactureraccessdata.fda.gov
Rongeur, MastoidJZA1Contract manufactureraccessdata.fda.gov
Rongeur, NasalKBB1Contract manufacturer, Manufactureraccessdata.fda.gov
Scissors, Collar And CrownEIR1Contract manufactureraccessdata.fda.gov
Scissors, EarJZB1Contract manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Contract manufactureraccessdata.fda.gov
Scissors, NasalKBD1Contract manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Contract manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Contract manufactureraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Contract manufactureraccessdata.fda.gov
Scissors, Wire Cutting, Ent, Non-SterileNNU1Contract manufactureraccessdata.fda.gov
System, Applicator, Radionuclide, Remote-ControlledJAQ2Manufactureraccessdata.fda.gov
Twister, WireHXS1Contract 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
July 10, 2020K201279ASSISTO Universal Applicator Clamping DeviceJAQSubstantially EquivalentGeomed Medizin-Technik GmbH & Co. KGaccessdata.fda.gov
September 3, 2019K183438Geomed Vascular DilatorsDWPSubstantially EquivalentGeomed Medizin-Technik GmbH & Co.accessdata.fda.gov
November 9, 2010K102048ATRAUMATIC VASCULAR CLAMPSDXCSubstantially EquivalentGeomed Medizin-Technik GmbH & Co. KGaccessdata.fda.gov
November 23, 2005K052745ASSISTO ARM SYSTEMSGWGSubstantially EquivalentGeomed Medizin-Technik GmbH & Co.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 16, 201160863Not yet classifiedTerminatedASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm Systems with a holding power of up to 50N are designed as univeThe product may fracture during surgical procedures.accessdata.fda.gov

Compare with other makers

Updated July 10, 2020. 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.