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Data / Medical devices / United States / Invotec International, Inc.

Invotec International, Inc.: FDA-registered device maker in Jacksonville, FL, United States, 14 510(k) clearances

Invotec International, Inc. is registered with the FDA (registration 1052728) in Jacksonville, FL, United States. It lists 34 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 31, 2013. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Invotec International, Inc.
FDA registration number
1052728
FEI number
1000113735
Address
6833 Phillips Industrial BLVD., Jacksonville, FL, United States, 32256
Owner or operator
INVOTEC INTERNATIONAL, INC. (9000512)
Roles
Manufacturer, Repackager or relabeler
First device listed
October 9, 1992
Registered through
2026
Brand names listed
AND THROAT, AntiFog, Audio Technologies Middle Ear Implants Total and Partials, BUR#EAR, Blades, Clearview Endoscope Cover, Disposable Ball Tip Direct Nerve Stimulator Probe, Disposable Bipolar Direct Nerve Stimulator Probe and more

Devices it lists

DeviceProduct codeClassRoleSource
Anti Fog Solution And Accessories, EndoscopyOCT2Repackager or relabeleraccessdata.fda.gov
Applicator, EntKCJ1Manufactureraccessdata.fda.gov
Balloon, EpistaxisEMX1Manufactureraccessdata.fda.gov
Blower, Powder, EntKCL1Repackager or relabeleraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Repackager or relabeleraccessdata.fda.gov
Button, Nasal SeptalLFBURepackager or relabeleraccessdata.fda.gov
Cement, Ear, Nose And ThroatNEA2Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Repackager or relabeleraccessdata.fda.gov
Device, Inflation, Middle EarMJVURepackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Hook, Microsurgical EarJYL1Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Repackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeleraccessdata.fda.gov
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)KHJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Prosthesis, Partial Ossicular ReplacementETB2Repackager or relabeleraccessdata.fda.gov
Protector, DentalBRW1Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Repackager or relabeleraccessdata.fda.gov
Replacement, Ossicular Prosthesis, TotalETA2Repackager or relabeleraccessdata.fda.gov
Scalpel, One-PieceGDX1Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Repackager or relabeleraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Splint, NasalEPP1Manufactureraccessdata.fda.gov
Sponge, OphthalmicHOZ2Repackager or relabeleraccessdata.fda.gov
Stimulator, NerveETN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Repackager or relabeleraccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Manufactureraccessdata.fda.gov
Tube, TympanostomyETD2Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Manufactureraccessdata.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
October 31, 2013K122040INVOTEC LARYNGEAL ELECTRODEETNSubstantially EquivalentInvotec International, Inc.accessdata.fda.gov
April 2, 2012K112426XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBESETNSubstantially EquivalentXian Friendship Medical Electronics Co., Ltd.accessdata.fda.gov
December 31, 2008K080740CLEARVIEW ENDOSCOPE COVEREOBSubstantially EquivalentInvotec International, Inc.accessdata.fda.gov
December 15, 2008K082460CENEFOM PVA SURGICAL SPEARHOZSubstantially EquivalentLongtek Scientific Co., Ltd.accessdata.fda.gov
January 9, 2007K063587XODUS MEDICAL ANTI-FOG SOLUTIONOCTSubstantially EquivalentXodus Medical, Inc.accessdata.fda.gov
December 6, 2005K051911GELITA-SPONKHJSubstantially EquivalentCuramedical, BVaccessdata.fda.gov
March 3, 2003K030492TITANIUM OSSICULAR REPLACMENT SYSTEMETASubstantially EquivalentInvotec International, Inc.accessdata.fda.gov
February 12, 2001K003567SERENOCEM, MODEL BC 010NEASubstantially EquivalentCorinthian Medical , Ltd.accessdata.fda.gov
June 23, 2000K001142AUDIO TECHNOLOGIES S:R.1ETBSubstantially EquivalentAudio Technologies S.R.L.accessdata.fda.gov
March 19, 1993K930114TRACHEOSTOMY T-TUBEBTRSubstantially EquivalentInvotec International, Inc.accessdata.fda.gov
October 5, 1992K920840OTOVENTMJVSubstantially EquivalentAbigo Medical ABaccessdata.fda.gov
September 9, 1992K923689SURGISTAR BLADESGDXSubstantially EquivalentSurgistar, Inc.accessdata.fda.gov
September 26, 1990K903285MICRO BRIGHT VENTILATION TUBESETDSubstantially EquivalentInvotec International, Inc.accessdata.fda.gov
June 14, 1990K901366INVOTEC SEPTAL BUTTONLFBSubstantially EquivalentInvotec International, Inc.accessdata.fda.gov

Compare with other makers

Updated October 31, 2013. 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.