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510(k) s clearances (Updated on January 15, 2024)

K NumberDateDevice NameCompanyProduct CodeReview Panel
K182065December 13, 2018EvoluxBlue Dent DentalEBGDental
K180626February 01, 2019Pedimax II – PedicularGM Dos ReisNKBOrthopedic
K182609March 29, 2019Delphos ImplantsDelphos ImplantsJEYDental
K182758December 05, 2019MCI - CMF SystemMCI MedicalJEY, DZLDental
K182718December 23, 2019Mini and Micro Fragments Reconstruction System – GMReisGM Dos ReisHRS, HWCOrthopedic
K183024February 13, 2020Implacil Implant SystemImplacil de BortoliDZL, NHADental
K200332October 29, 2020EXPERT – Joint FixationGM Dos ReisHTNOrthopedic
K212729May 31, 2022 Bone Cement-Normal ViscosityBiomecanica Indústria e Comércio de Produtos OrtopédicosLODOrthopedic
K192839February 11, 2021DSP Implant SystemD.S.P Industrial EireliDZE, NHADental
K201728March 08, 2021Versalock Periprosthetic Femur Plates SystemGM dos Reis Industria e Comercio LtdaHRS, JDP, HWC, JDQOrthopedic
K221329February 22, 2023Eyer Retinal Camera NM-STDPhelcom TechnologiesHKIOphthalmic
K222847May 04, 2023Ceramic Brackets OrthometricOrthometric - Industria e Comercio de Produtos MedicosNJM Dental
K223114August 02, 2023Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM Dos ReisMBIOrthopedic
K221851December 08, 2023Lumina-PTFE TitaniumCriteria Industria E Comercio De Produtos Medicinais
E Odontologicos LTDA		NPKDental

Medical Device Establishment Registration and Listing (Updated on January 15, 2024)

CompanyEstablishment Registration
3R INDUSTRIA E COMERCIO LTDAView Registration
ATRASORB INDUSTRIA DE PRODUTOS HOSPITALARESView Registration
BIOTECNO INDUSTRIA E COMERCIO LTDAView Registration
BLUE DENT DENTALView Registration
D.S.P. INDUSTRIAL EIRELI EPPView Registration
GM DOS REIS INDUSTRIA E COMERCIO LTDAView Registration
IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDAView Registration
MEDPEJ EQUIPAMENTOS MEDICOS LTDAView Registration
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDAView Registration
OSTEOMED IMPLANTESView Registration
PHELCOM TECHNOLOGIESView Registration
RAZEK EQUIPAMENTOS LTDAView Registration
RUSSER BRASIL LTDAView Registration
SCHOBELL INDUSTRIAL LTDAView Registration
VOLMED BRASIL EQUIPAMENTOS LTDAView Registration

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