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Data / Medical devices / Germany / Instrumed GmbH dba Avalign German Specialty Instruments

Instrumed GmbH dba Avalign German Specialty Instruments: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 3 510(k) clearances

Instrumed GmbH dba Avalign German Specialty Instruments is registered with the FDA (registration 8010372) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 99 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 3, 2009. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Instrumed GmbH dba Avalign German Specialty Instruments
FDA registration number
8010372
FEI number
3007290840
Address
3 Unter Buchsteig, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator
Avalign Technologies (10051835)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
May 9, 2016
Registered through
2027
Brand names listed
Joint Aspiration Tray

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
Aspiration TrayOJT1Contract manufactureraccessdata.fda.gov
Bar, PreformedEHO1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Caliper, OphthalmicHOE1Manufactureraccessdata.fda.gov
Cannula, EarJYC1Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufactureraccessdata.fda.gov
Chisel, Middle-EarJYE1Contract manufacturer, Manufactureraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Manufactureraccessdata.fda.gov
ClampHXD1Manufactureraccessdata.fda.gov
Clamp, VascularDXC2Contract manufacturer, Manufactureraccessdata.fda.gov
Crimper, Wire, Ent, Non-SterileNNN1Manufactureraccessdata.fda.gov
CuretteHTF1Contract manufactureraccessdata.fda.gov
Curette, EarJYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufactureraccessdata.fda.gov
Dilator, LachrymalHNW1Contract manufacturer, Manufactureraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Contract manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Elevator, EntKAD1Contract manufacturer, Manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Contract manufactureraccessdata.fda.gov
Excavator, EarJYH1Contract manufacturer, Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Manufactureraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Manufactureraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Contract manufactureraccessdata.fda.gov
ForkHXE1Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Contract manufactureraccessdata.fda.gov
HemostatHRQ1Manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Contract manufactureraccessdata.fda.gov
Hook, Microsurgical EarJYL1Contract manufacturer, Manufactureraccessdata.fda.gov
Hook, OphthalmicHNQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Contract manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Manufactureraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Contract manufacturer, Manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufacturer, Manufactureraccessdata.fda.gov
Knife, AmputationGDN1Manufactureraccessdata.fda.gov
Knife, EarJYO1Contract manufactureraccessdata.fda.gov
Knife, EntKTG1Manufactureraccessdata.fda.gov
Knife, LaryngealJZY1Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Contract manufacturer, Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Contract manufactureraccessdata.fda.gov
Marker, SkinFZZ1Manufactureraccessdata.fda.gov
Mirror, EntKAI1Manufactureraccessdata.fda.gov
Mobilizer, EntKAJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Gastro-UrologyFHR1Manufactureraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
OsteotomeHWM1Contract manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Contract manufacturer, Manufactureraccessdata.fda.gov
PasserHWQ1Manufactureraccessdata.fda.gov
Pick, Microsurgical EarJYT1Contract manufacturer, Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Manufactureraccessdata.fda.gov
ProbeHXB1Contract manufacturer, Manufactureraccessdata.fda.gov
Probe, EntKAK1Contract manufacturer, Manufactureraccessdata.fda.gov
Punch, AntrumKAW1Manufactureraccessdata.fda.gov
Punch, EntKTF1Manufactureraccessdata.fda.gov
RaspHTR1Contract manufactureraccessdata.fda.gov
Rasp, EarJYY1Contract manufacturer, Manufactureraccessdata.fda.gov
Rasp, NasalKBA1Manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Retractor, EntKAL1Contract manufacturer, Manufactureraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufactureraccessdata.fda.gov
Retractor, VaginalHDL1Manufactureraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Manufactureraccessdata.fda.gov
Rod, Measuring EarJYZ1Contract manufacturer, Manufactureraccessdata.fda.gov
RongeurHTX1Contract manufactureraccessdata.fda.gov
Scissors, EarJZB1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Contract manufactureraccessdata.fda.gov
Scissors, NasalKBD1Specification developeraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Spatula, OphthalmicHND1Manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Manufactureraccessdata.fda.gov
Stripper, SurgicalHRT1Manufactureraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Contract manufactureraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Contract manufactureraccessdata.fda.gov
Tube, Ear SuctionJZF1Manufactureraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Manufactureraccessdata.fda.gov
Twister, WireHXS1Manufactureraccessdata.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
December 3, 2009K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
April 16, 2004K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEISubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
June 18, 1998K980002KOALA VASCULAR CLAMPS AND INSERTSDXCSubstantially EquivalentBoss Instruments, Ltd.accessdata.fda.gov

Compare with other makers

Updated December 3, 2009. 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.