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

NJM 2017-06-14

C-Line Orthodontic Ceramic Bracket

Applicant Biocetec Co., Ltd.

K-Number K163467

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LPH 2017-06-14

iTotal® Hip Replacement System

Applicant Conformis, Inc.

K-Number K162719

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PNO 2017-06-14

UltraScore Focused Force PTA Balloon

Applicant Bard Peripheral Vascular, Inc.

K-Number K163420

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NUP 2017-06-14

Alzair Allergy Blocker

Applicant Nasaleze International, Ltd.

K-Number K170848

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MQE 2017-06-14

Follicle Aspiration Set

Applicant Vitrolife Sweden AB

K-Number K161970

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JAK 2017-06-14

BodyTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung Electronics

K-Number K170238

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LNH 2017-06-14

MAGNETOM Vida

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170396

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KHE 2017-06-14

hema-screen SPECIFIC Gold

Applicant Immunostics Inc.,

K-Number K171484

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HRS 2017-06-14

EVOS Small Fragment Lower Extremity Plates

Applicant Smith & Nephew, Inc.

K-Number K170457

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IYN 2017-06-14

Vivid S60N, Vivid S70N

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K170878

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LLZ 2017-06-14

EchoPAC Software Only, EchoPAC Plug-in

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K170847

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FCG 2017-06-14

Howell Biliary Introducer Needle

Applicant Wilson-Cook Medical, Inc.

K-Number K160890

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