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Data / Medical devices / Germany / Evonos GMBH & Co. KG

Evonos GMBH & Co. KG: FDA-registered device maker in Tuttlingen Baden-Wurttemberg, Germany, 1 510(k) clearance

Evonos GMBH & Co. KG is registered with the FDA (registration 3010726901) in Tuttlingen Baden-Wurttemberg, Germany. It lists 64 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 6, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Evonos GMBH & Co. KG
FDA registration number
3010726901
Address
Stockacher Strasse 134, Tuttlingen Baden-Wurttemberg, Germany, 78532
Owner or operator
evonos GmbH & Co. KG (10048205)
Roles
Contract manufacturer, Manufacturer
First device listed
April 22, 2015
Registered through
2026
Brand names listed
Osteotome, acc. to Sheehan, hexagonal handle, straight, size 3 x 160, Osteotome, acc. to Sheehan, hexagonal handle, straight, size 8 x 160, Sickle knife "Richards", sharp, size 190, Suction tube "Velvet Eye", tip closed, with 2 lateral holes, size 220, WILLIAMS MICROCLIP INSERTER

Devices it lists

DeviceProduct codeClassRoleSource
AdenotomeKBH1Manufactureraccessdata.fda.gov
Applicator, EntKCJ1Manufactureraccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Manufactureraccessdata.fda.gov
Brush, Biopsy, General & Plastic SurgeryGEE1Manufactureraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Curette, EarJYG1Manufactureraccessdata.fda.gov
Curette, NasalKAP1Manufactureraccessdata.fda.gov
Dilator, TrachealKCG1Manufactureraccessdata.fda.gov
Dissector, TonsilKBM1Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Compound, Powered)HBF2Manufactureraccessdata.fda.gov
Elevator, EntKAD1Manufactureraccessdata.fda.gov
Excavator, EarJYH1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Manufactureraccessdata.fda.gov
Fork, TuningGWX1Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Manufactureraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Hoe, PeriodonticEMQ1Manufactureraccessdata.fda.gov
Holder, Ear SpeculumJYK1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
Hook, Microsurgical EarJYL1Manufactureraccessdata.fda.gov
Inserter, Myringotomy TubeJYM1Manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Jig, Piston Cutting, Ent, Non-SterileNNO1Manufactureraccessdata.fda.gov
Knife, EarJYO1Manufactureraccessdata.fda.gov
Knife, EntKTG1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Light, Surgical HeadlightEBA1Manufactureraccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Mirror, EntKAI1Manufactureraccessdata.fda.gov
Mirror, Headband, OphthalmicHKF1Manufactureraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Manufactureraccessdata.fda.gov
Perforator, Ear-LobeJYS1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Press, VeinJYW1Manufactureraccessdata.fda.gov
Probe, EntKAK1Manufactureraccessdata.fda.gov
Punch, EntKTF1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
Rasp, EarJYY1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, EntKAL1Contract manufacturer, Manufactureraccessdata.fda.gov
Rongeur, NasalKBB1Manufactureraccessdata.fda.gov
Saw, NasalKBC1Manufactureraccessdata.fda.gov
Scissors, EarJZB1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Slides, MicroscopeKEW1Manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Transilluminator, Fiber OpticMQW1Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Manufactureraccessdata.fda.gov
Tray, Surgical, EntMMO1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufacturer, Manufactureraccessdata.fda.gov
TrephineHWK1Manufactureraccessdata.fda.gov
Trocar, EntKTE1Manufactureraccessdata.fda.gov
Tube, Ear SuctionJZF1Manufactureraccessdata.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
March 6, 2024K231403evoDrill Cranial PerforatorHBFSubstantially EquivalentEvonos GmbH & Co. KGaccessdata.fda.gov

Compare with other makers

Updated March 6, 2024. 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.