Skip to the page
Get started free

Data / Medical devices / Germany / Tekno Medical Optik-Chirurgie GMBH

Tekno Medical Optik-Chirurgie GMBH: FDA-registered device maker in TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany, 21 510(k) clearances

Tekno Medical Optik-Chirurgie GMBH is registered with the FDA (registration 9611503) in TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany. It lists 146 device types. The FDA files 21 510(k) clearances under its listings, the newest dated June 8, 2018. Registered through 2026. 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 Tekno Medical Optik-Chirurgie GMBH
FDA registration number
9611503
FEI number
3002808335
Address
Sattlerstrasse 11, TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany, 78532
Owner or operator
TEKNO-MEDICAL OPTIK-CHIRURGIE GMBH (10027774)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 2, 2008
Registered through
2026
Brand names listed
Atria 1 (LED, Single Color), Atria 2 (LED, Single Color), Atria 3 (LED, Single Color), Atria 5 (LED, Single- / Multicolor), Atria 7 (LED, Single- / Multicolor), Head Mirror, VISUAL OBTURATOR FOR HYBRID RESECTOSCOPE

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suturing, Stomach And IntestinalFHM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Applicator, EntKCJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Applicator, VaginalHGD1Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apron, LeadedEAJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
Bistoury, TrachealKCC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blower, Powder, EntKCL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, InjectionFGY1Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Continuous IrrigationGBQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ClampHXD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, PenileFHA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, OphthalmicHNZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, DentalEMK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
DermatomeGFD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dislodger, Stone, FlexibleFGO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Explorer, OperativeEKB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ExtractorHWB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
File, Bone, SurgicalEMI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Articulation PaperEFK1Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Fork, TuningGWX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Frame, Rubber DamEJE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hook, Microsurgical EarJYL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Knife, AmputationGDN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lamp, Operating-RoomFQP2Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Repackager or relabeleraccessdata.fda.gov
Light Source, Endoscope, Xenon ArcGCT2Repackager or relabeleraccessdata.fda.gov
Light, Surgical HeadlightEBA1Repackager or relabeleraccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
MalletHXL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mediastinoscope, SurgicalEWY2Contract manufactureraccessdata.fda.gov
Mirror, EntKAI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nipper, MalleusJYR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
PinwheelGWY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Razor, SurgicalLWK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retainer, MatrixJEP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Rongeur, ManualHAE2Contract manufactureraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Collar And CrownEIR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, EpisiotomyHDK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, UmbilicalHDJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Snare, TonsilKBZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Spreader, Bladder NeckFHK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Repackager or relabeleraccessdata.fda.gov
Tap, BoneHWX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Trocar, EntKTE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, LaryngectomyKAC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Manufactureraccessdata.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 8, 2018K173070HSW Resection InstrumentsHIHSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
December 7, 2017K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathFAJSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
June 20, 2012K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESFASSubstantially EquivalentOlympus Winter & Ibe GmbHaccessdata.fda.gov
February 20, 2007K070102SOPRO 162 CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
July 12, 2006K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESGEISubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
October 27, 2004K042077BITECH BIPOLAR SCISSORSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
May 17, 2004K040390STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEMHIHSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
March 11, 2004K033177POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXXHETSubstantially EquivalentGunter Bissinger Medizintechnik GmbHaccessdata.fda.gov
September 29, 2003K031974ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0HIHSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov
September 16, 2003K031593SOPRO 61DGCJSubstantially EquivalentSoproaccessdata.fda.gov
September 15, 2003K031972ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,HRXSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov
June 30, 2003K031141ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPEFAJSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.fda.gov
March 14, 2002K020270SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
December 13, 2001K013090SOPRO 67D OPERATING ROOM CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
March 1, 2001K003717INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAFGEISubstantially EquivalentTekno Medical Optik-Chirurgie GmbH & Co.accessdata.fda.gov
October 7, 1999K992983BAHO AUTOCLAVABLE CYSTOSCOPEFAJSubstantially EquivalentInnovative Endoscopy Components, LLCaccessdata.fda.gov
February 18, 1999K982276BAHO AUTOCLAVABLE LAPAROSCOPEHETSubstantially EquivalentMicroptix Int'L, LLCaccessdata.fda.gov
August 6, 1998K981919BISSINGER CABLES, CAT. NO. 801000XXGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
May 21, 1998K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPSHETSubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
September 11, 1996K962330AMO ARTHOSCOPESHRXSubstantially EquivalentAmerican Microptiks, Inc.accessdata.fda.gov

Compare with other makers

Updated June 8, 2018. 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.