• 510 (k) approved

510(k)s clearances (updated on July 7, 2022)

K number
Date
Product name
Company
Product code
Review Panel
K182065
Dec 13, 2018
Evolux
Blue Dent Dental
EBG
Dental
K180626
Fev 01, 2019
Pedimax II – Pedicular
GM Dos Reis
NKB
Orthopedic
K182609
Mar 29, 2019
Delphos Implants
Delphos Implants
JEY
Dental
K182758
Dec 05, 2019
MCI – CMF
MCI Medical
JEY, DZL
Dental
K182718
Dec 23, 2019
 GMReis
GM Dos Reis
HRS, HWC
Orthopedic
K183024
Fev 13, 2020
Implacil Implant
Implacil de Bortoli
DZL, NHA
Dental
K200332
Oct 29, 2020
EXPERT – Joint Fixation
GM Dos Reis
HTN
Orthopedic
K212729
May 31, 2022
Bone Cement
Normal Viscosity
Biomecanica Indústria e Comércio de Produtos Ortopédicos
Orthopedic
K192839
Feb 11, 2021
DSP Implant System
D.S.P Industrial Eireli
DZE, NHA –   LOD
Dental
K201728
March 8, 2021
Versalock Periprosthetic Femur Plates System
GM dos Reis Industria e Comercio Ltda
HRS, JDP, HWC, JDQ
Orthopedic

Medical Device Establishment Registration and Listing (updated on July 4, 2022)

Company

Establishment Registration

3R INDUSTRIA E COMERCIO LTDA
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ATRASORB INDUSTRIA DE PRODUTOS HOSPITALARES
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BLUE DENT DENTAL
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CARCI INDUSTRIA E COMERCIO DE APARELHOS CIRURGICOS E ORTOPEDICOS EIRELI
View Registration
CREMER S.A.
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DELPHOS IMPLANTS – IND. COM. IMPORTACAO E EXPORTACAO DE IMPL
View Registration
DORJA INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA
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GM DOS REIS INDUSTRIA E COMERCIO LTDA
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IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA
View Registration
INDREL SCIENTIFIC
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MCI MEDICAL CONCEPT INNOVATION INC.
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SCHOBELL INDUSTRIAL LTDA
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RUSSER BRASIL LTDA
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VOLMED BRASIL EQUIPAMENTOS LTDA
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BIOTECNO INDUSTRIA E COMERCIO LTDA
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BIONNOVATION PRODUTOS BIOMEDICOS LTDA
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D.S.P. INDUSTRIAL EIRELI EPP
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MEDPEJ EQUIPAMENTOS MEDICOS LTDA
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OSTEOMED IMPLANTES
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PHELCOM TECHNOLOGIES
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RAZEK EQUIPAMENTOS LTDA
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ZAMMI INSTRUMENTAL LTDA
View Registration