• 510 (k) approved

510(k)s clearances (updated on February 11, 2021)

 

K number Date Product name Company Product code Review Panel
K182065
13/12/2018
Evolux
Blue Dent Dental
EBG
Dental
K180626
01/02/2019
Pedimax II – Pedicular
GM Dos Reis
NKB
Orthopedic
K182609
29/03/2019
Delphos Implants
Delphos Implants
JEY
Dental
K182758
05/12/2019
MCI – CMF
MCI Medical
JEY, DZL
Dental
K182718
23/12/2019
GMReis
GM Dos Reis
HRS, HWC
Orthopedic
K183024
13/02/2020
Implacil Implant
Implacil de Bortoli
DZL, NHA
Dental
K200332
29/10/2020
EXPERT – Joint Fixation
GM Dos Reis
HTN

Medical Device Establishment Registration and Listing (updated on February 11, 2021)

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

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CREMER S.A.

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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

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IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA

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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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