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

OAS 2016-09-30

DENTRIa series

Applicant Hdx Will Corp.

K-Number K160140

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ELW 2016-09-30

i-Sil

Applicant Spident Co., Ltd.

K-Number K161774

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OOD 2016-09-29

Phasix Mesh

Applicant C.R. Bard, Inc.

K-Number K161424

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GEI 2016-09-29

Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

Applicant ArthroCare Corporation

K-Number K162126

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MAX 2016-09-29

nva, nvp, and nvt

Applicant Nvision Biomedical Technologies, LLC

K-Number K162426

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FCX 2016-09-29

Nexcore GI Insufflator

Applicant Nexcore Technology, LLC

K-Number K162332

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LXB 2016-09-29

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

Applicant Oticon Medical AB

K-Number K161671

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NHA 2016-09-29

CreoDent Solidex Custom Abutment

Applicant Creodent Prosthetics, Ltd.

K-Number K160436

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OMP 2016-09-29

RENASYS GO

Applicant Smith & Nephew, Inc.

K-Number K152163

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GCJ 2016-09-29

EZEE RETRIEVAL

Applicant Genicon, Inc.

K-Number K162059

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GEX 2016-09-29

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

Applicant Iridex Corporation

K-Number K162416

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GBM 2016-09-29

SpeediCath Flex Coude

Applicant Coloplast Corp.

K-Number K161672

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