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Data / Medical devices / United States / Medegen Medical Products

Medegen Medical Products: FDA-registered device maker in Gallaway, TN, United States, 5 510(k) clearances

Medegen Medical Products is registered with the FDA (registration 1043646) in Gallaway, TN, United States. It lists 36 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 13, 2003. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1043646
Address
209 Medegen DR., Gallaway, TN, United States, 38036
Owner or operator
Medegen Medical Products (9005738)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 31, 2001
Registered through
2026
Brand names listed
; All Purpose Clamp, Apron, BEDPAN, BOWL STAND IV, Barrier Sleeves, Bowls, Calculi Strainer, Cane and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Specification developeraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Specification developeraccessdata.fda.gov
Basin, EmesisFNY1Contract manufacturer, Manufactureraccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
BedpanFOB1Manufactureraccessdata.fda.gov
Body Fluid Clean Up KitOKG2Repackager or relabeler, Specification developeraccessdata.fda.gov
CaneIPS1Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Specification developeraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Specification developeraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Specification developeraccessdata.fda.gov
CrutchIPR1Specification developeraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Specification developeraccessdata.fda.gov
Device, Specimen CollectionLIO1Specification developeraccessdata.fda.gov
Dish, Tissue CultureKIZ1Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Douche Apparatus, Vaginal, TherapeuticHED1Specification developeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Specification developeraccessdata.fda.gov
Enema KitFCE1Specification developeraccessdata.fda.gov
Gown, ExaminationFME1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufacturer, Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Specification developeraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Specification developeraccessdata.fda.gov
Tips And Pads, Cane, Crutch And WalkerINP1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
UrinalFNP1Manufactureraccessdata.fda.gov
Walker, MechanicalITJ1Specification developeraccessdata.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
August 13, 2003K032246MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEMJSMSubstantially EquivalentStarplex Scientific, Inc.accessdata.fda.gov
April 3, 1996K960997STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEMLIOSubstantially EquivalentStarplex Scientific, Inc.accessdata.fda.gov
November 30, 1994K943499KULTSURE STARSWAB(M240), MODIFICATIONJSMSubstantially EquivalentNcs Diagnostics, Inc.accessdata.fda.gov
August 23, 1994K942054SHARPS-TAINERFMISubstantially EquivalentWinfield Industriesaccessdata.fda.gov
February 21, 1985K850199POLY-LINED TOWEL/DRAPE LINEKKXSubstantially EquivalentExcel Health Care Productsaccessdata.fda.gov

Compare with other makers

Updated August 13, 2003. 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.