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 2018-03-16

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

Applicant 3M Healthcare

K-Number K180404

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LSL 2018-03-16

Xpert CT/NG

Applicant Cepheid

K-Number K173840

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OUR 2018-03-16

SI Screw System

Applicant Zavation Medical Products, LLC

K-Number K173752

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MDB 2018-03-16

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial

Applicant Becton, Dickinson and Company

K-Number K173873

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HQD 2018-03-16

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG

Applicant Paragon Vision Sciences

K-Number K180172

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HRN 2018-03-16

Frigitronics adapter

Applicant Phakos

K-Number K180195

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NHA 2018-03-16

CCM Abutment System

Applicant Innobiosurg Co., Ltd.

K-Number K173120

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LFD 2018-03-16

TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

Applicant Dr. Harold Katz, LLC (Dba Therabreath

K-Number K171542

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MIB 2018-03-16

SOFTXIL

Applicant Bistool

K-Number K171851

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LLZ 2018-03-16

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173611

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BZK 2018-03-16

ExSpiron 1Xi

Applicant Respiratory Motion, Inc.

K-Number K173181

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LLZ 2018-03-16

Imbio Segmentation Editing Tool software

Applicant Imbio, LLC

K-Number K180129

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