Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FGE 2017-08-09

Epic Biliary Endoscopic Stent System

Applicant Boston Scientific Corporation

K-Number K171809

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OZE 2017-08-09

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

Applicant Centers for Disease Control and Prevention

K-Number K172091

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IYN 2017-08-08

HS40 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K172129

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NHA 2017-08-08

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K170588

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DBM 2017-08-08

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA

Applicant Immco Diagnostics, Inc.

K-Number K163133

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OOX 2017-08-08

AFIAS iFOB with AFIAS-50

Applicant Immunostics Inc.,

K-Number K163225

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JEY 2017-08-08

TruMatch CMF Titanium 3D Printed Implant System

Applicant Materialise NV

K-Number K170272

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KYF 2017-08-08

Ahmed Glaucoma Valve Model FP8

Applicant New World Medical, Inc.

K-Number K171451

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OWI 2017-08-08

JAZZ Passer Band

Applicant Implanet, S.A.

K-Number K171881

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JWH 2017-08-08

EVOLUTION Revision CCK System

Applicant Microport Orthopedics, Inc.

K-Number K171389

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PTI 2017-08-08

PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set

Applicant C.R. Bard, Inc.

K-Number K171735

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LZO 2017-08-08

MiniMAX

Applicant Medacta International S.A.

K-Number K170845

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