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Data / Medical devices / Germany / Amnotec International Medical GMBH

Amnotec International Medical GMBH: FDA-registered device maker in Neuhausen ob Eck Baden-Wurttemberg, Germany, 17 510(k) clearances

Amnotec International Medical GMBH is registered with the FDA (registration 3014615697) in Neuhausen ob Eck Baden-Wurttemberg, Germany. It lists 119 device types. The FDA files 17 510(k) clearances under its listings, the newest dated February 18, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Amnotec International Medical GMBH
FDA registration number
3014615697
Address
Take-Off-Gewerbepark 12, Neuhausen ob Eck Baden-Wurttemberg, Germany, 78579
Owner or operator
Amnotec International Medical GmbH (10057846)
Roles
Repackager or relabeler
First device listed
June 2, 2018
Registered through
2026
Brand names listed
London College

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
AdenotomeKBH1Repackager or relabeleraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bougie, UrologicalFAX1Repackager or relabeleraccessdata.fda.gov
Brace, DrillHXY1Repackager or relabeleraccessdata.fda.gov
Cannula, EarJYC1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Repackager or relabeleraccessdata.fda.gov
Chisel (Osteotome)KDG1Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeleraccessdata.fda.gov
Chisel, MastoidJYD1Repackager or relabeleraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Repackager or relabeleraccessdata.fda.gov
Clamp, PenileFHA1Repackager or relabeleraccessdata.fda.gov
Clamp, Rubber DamEEF1Repackager or relabeleraccessdata.fda.gov
Clamp, UterineHGC1Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Repackager or relabeleraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Dissector, TonsilKBM1Repackager or relabeleraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Repackager or relabeleraccessdata.fda.gov
File, Surgical, General & Plastic SurgeryGEO1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Forceps, Wire Closure, Ent, SterileJXX1Repackager or relabeleraccessdata.fda.gov
Frame, Rubber DamEJE1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Repackager or relabeleraccessdata.fda.gov
Guillotine, TonsilKBO1Repackager or relabeleraccessdata.fda.gov
Halter, Head, TractionHSS1Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Repackager or relabeleraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Repackager or relabeleraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Repackager or relabeleraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Repackager or relabeleraccessdata.fda.gov
Knife, AmputationGDN1Repackager or relabeleraccessdata.fda.gov
Knife, MyringotomyJYP1Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Repackager or relabeleraccessdata.fda.gov
Knife, OphthalmicHNN1Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Repackager or relabeleraccessdata.fda.gov
Lithotriptor, Biliary MechanicalLQC2Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Repackager or relabeleraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Repackager or relabeleraccessdata.fda.gov
Nipper, MalleusJYR1Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager or relabeleraccessdata.fda.gov
PinwheelGWY1Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Repackager or relabeleraccessdata.fda.gov
Punch, SkullGXJ1Repackager or relabeleraccessdata.fda.gov
Razor, SurgicalLWK1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
Ring CutterFNS1Repackager or relabeleraccessdata.fda.gov
Saw, NasalKBC1Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Scissors, UmbilicalHDJ1Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Snare, EarJZD1Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Repackager or relabeleraccessdata.fda.gov
Snare, TonsilKBZ1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Spoon, EarJZE1Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Trocar, SinusKBG1Repackager or relabeleraccessdata.fda.gov
Trocar, TrachealKCI1Repackager or relabeleraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Repackager or relabeleraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Repackager or relabeleraccessdata.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
February 18, 2023K221861FloNavi Endoscopic Fluorescence Imaging SystemGCJSubstantially EquivalentGuangdong Optomedic Technologies, Inc.accessdata.fda.gov
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
March 18, 2008K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRXSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
December 8, 2006K062707RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPEFGBSubstantially EquivalentInnovative Endoscopy Components, LLCaccessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
July 12, 2006K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESGEISubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
March 24, 2005K050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEGCJSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
June 30, 2003K031141ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPEFAJSubstantially EquivalentAsap Endoscopic Products GmbHaccessdata.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 13, 1998K981751SINUSCOPE AND ACCESSORIESEOBSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.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
May 16, 1994K941967HSW LAPAROSCOPE AND ACCESSORIESGCJSubstantially EquivalentHenke-Sass, Wolf GmbHaccessdata.fda.gov
May 16, 1994K941541HSV LAPAROSCOPY SETGCJSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
March 14, 1994K935442MAHE INSTRUMENTSGCJSubstantially EquivalentMahe-Medizintechnikaccessdata.fda.gov

Compare with other makers

Updated February 18, 2023. 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.