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Data / Medical devices / United States / Medinova Group Co.

Medinova Group Co.: FDA-registered device maker in Laguna Beach, CA, United States, 2 510(k) clearances

Medinova Group Co. is registered with the FDA (registration 3044466317) in Laguna Beach, CA, United States. It lists 34 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 3, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3044466317
Address
1968 S. Coast Hwy Suite 861, Laguna Beach, CA, United States, 92651
Owner or operator
Medinova Group Co. (10085921)
Roles
Complaint file establishment, Manufacturer for export
First device listed
September 9, 2022
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Complaint file establishmentaccessdata.fda.gov
Adhesive Backed Thermal Skin PatchesOMW1Complaint file establishmentaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Complaint file establishmentaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Complaint file establishmentaccessdata.fda.gov
Bandage, CastITG1Complaint file establishmentaccessdata.fda.gov
Bandage, ElasticFQM1Complaint file establishmentaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Complaint file establishmentaccessdata.fda.gov
Container, SharpsMMK2Complaint file establishmentaccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Complaint file establishmentaccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Complaint file establishmentaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishmentaccessdata.fda.gov
Container, Specimen, SterileFMH1Complaint file establishmentaccessdata.fda.gov
Cotton, RollEFN1Complaint file establishmentaccessdata.fda.gov
Coverslips, Microscope SlideKES1Complaint file establishmentaccessdata.fda.gov
Culture Media, Non-Selective And Non-DifferentialJSG1Complaint file establishmentaccessdata.fda.gov
Dish, Tissue CultureKIZ1Complaint file establishmentaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Complaint file establishmentaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufacturer for exportaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Complaint file establishmentaccessdata.fda.gov
ForcepsHTD1Complaint file establishmentaccessdata.fda.gov
Kit, First Aid, TalkingOVR1Complaint file establishmentaccessdata.fda.gov
Micro PipetteJRC1Complaint file establishmentaccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Complaint file establishmentaccessdata.fda.gov
Pad, EyeHMP1Complaint file establishmentaccessdata.fda.gov
Pipette, PasteurGJW1Complaint file establishmentaccessdata.fda.gov
Punch, Gelfoam, Non-SterileNNT1Complaint file establishmentaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Complaint file establishmentaccessdata.fda.gov
Slides, MicroscopeKEW1Complaint file establishmentaccessdata.fda.gov
Suit, SurgicalFXO1Complaint file establishmentaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishmentaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishmentaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Complaint file establishmentaccessdata.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
January 3, 2019K180984Maxcon Sharps ContainerMMKSubstantially EquivalentNingbo Maxcon Medical Technology Co., Ltd.accessdata.fda.gov
July 12, 2010K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBEJKASubstantially EquivalentGuangzhou Improve Medical Instruments Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 3, 2019. 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.