Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

DFH 2018-08-23

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

Applicant The Binding Site Group , Ltd.

K-Number K173732

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JWH 2018-08-23

GMK Sphere CR Tibial Inserts

Applicant Medacta International S.A.

K-Number K181635

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JWH 2018-08-23

GMK Sphere - Kinematic Alignment

Applicant Medacta International S.A.

K-Number K173890

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FBN 2018-08-23

SpyGlass DS and DS II Direct Visualization System

Applicant Boston Scientific Corporation

K-Number K181439

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NXC 2018-08-23

Smylic Invisible Clear Aligners

Applicant Smylio, Inc.

K-Number K173784

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MXJ 2018-08-23

ADVIA Centaur Herpes-1 IgG

Applicant Biokit, S.A.

K-Number K181333

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MYF 2018-08-23

ADVIA Centaur Herpes-2 IgG

Applicant Biokit, S.A.

K-Number K181334

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EZL 2018-08-23

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

Applicant Cook Incorporated

K-Number K173657

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EIH 2018-08-23

Z-CAD smile

Applicant Metoxit AG

K-Number K170050

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DXN 2018-08-22

Non-invasive blood pressure measurement systems

Applicant Joytech Healthcare Co. , Ltd.

K-Number K173024

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PDQ 2018-08-22

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

Applicant Boston Endo Surgical Tech,

K-Number K180542

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CAC 2018-08-22

autoLog IQ Autotransfusion System

Applicant Medtronic Perfusion Systems

K-Number K181954

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