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