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 2016-08-26

ORTHODONTIC CERAMIC BRACKETS 1.1

Applicant Tomy, Inc.

K-Number K160615

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FRO 2016-08-25

Exufiber Ag+

Applicant Molnlycke Health Care Us, LLC

K-Number K160379

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FDF 2016-08-25

invendoscopy E200 System

Applicant Invendo Medical GmbH

K-Number K161355

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DCF 2016-08-25

Optilite Low Level Albumin Kit

Applicant The Binding Site Group , Ltd.

K-Number K153560

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ERL 2016-08-25

DragonFly Surgical Drill System

Applicant Grace Medical, Inc.

K-Number K161376

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OWB 2016-08-25

AneurysmFlow

Applicant Philips Medical Systems Nederland B.V.

K-Number K160455

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DYB 2016-08-25

HQS Introducer (Model 2064-HQS)

Applicant Alseal

K-Number K153494

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DQY 2016-08-25

ASAHI Corsair Pro

Applicant Asahi Intecc Co., Ltd.

K-Number K161126

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PHX 2016-08-25

Integra TITAN Reverse Shoulder System

Applicant Integra LifeSciences Corporation

K-Number K161189

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MAX 2016-08-25

NuVasive Lumbar Interbody Implants

Applicant Nu Vasive, Incorporated

K-Number K161230

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LSR 2016-08-25

Anti-Borrelia burgdorferi US Westernblot (IgG)

Applicant Euroimmun US

K-Number K161513

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LOL 2016-08-25

LIAISON HAV IgM, LIAISON Control HAV IgM

Applicant DiaSorin, Inc.

K-Number K160650

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