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

KWQ 2016-08-23

ZION Anterior Cervical Fixation System

Applicant Astura Medical

K-Number K160702

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KLW 2016-08-23

HyperSound Tinnitus Module

Applicant Turtle Beach Corporation

K-Number K161331

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GEH 2016-08-23

Accurett

Applicant H&O Equipments, Nv/Sa

K-Number K161615

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EBF 2016-08-23

KATANA AVENCIA Block

Applicant Kuraray Noritake Dental, Inc.

K-Number K153476

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OOD 2016-08-23

GalaSHAPE 3D

Applicant Tepha, Inc.

K-Number K161092

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LNH 2016-08-23

Vantage Titan 1.5T, MRT-1510, V3.6 Software

Applicant Toshibamedical Systems Corporation

K-Number K160632

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OKP 2016-08-23

sTMS mini

Applicant Eneura, Inc.

K-Number K161663

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KMF 2016-08-23

Cavilon Advanced High Endurance Skin Protectant

Applicant 3M Healthcare

K-Number K153571

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MEH 2016-08-22

H-Max S stem

Applicant Lima Corporate S.P.A.

K-Number K160011

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NKG 2016-08-22

Streamline OCT Occipito-Cervico-Thoracic System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K-Number K161498

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LPL 2016-08-22

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

Applicant Joowon Innovation Co., Ltd.

K-Number K161098

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MNI 2016-08-22

Double Medical Universal Spine System

Applicant Double Medical Technology, Inc.

K-Number K151458

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