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

NHA 2016-04-15

Neodent Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S

K-Number K153624

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LNH 2016-04-15

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K153343

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ONN 2016-04-15

VERASENSE Knee System

Applicant Orthosensor, Inc.

K-Number K150372

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MUH 2016-04-15

RIOScan (RPS500)

Applicant Ray Co., Ltd.

K-Number K160788

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ONF 2016-04-15

Forma System, Forma Light System

Applicant Formatk Systems , Ltd.

K-Number K160195

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EZL 2016-04-15

Accuryn Monitoring System

Applicant Potrero Medical, Inc.

K-Number K153655

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LON 2016-04-15

VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

Applicant bioMerieux, Inc.

K-Number K152075

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MAX 2016-04-15

Leva Spacer System

Applicant Spine Wave, Inc.

K-Number K153222

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KOC 2016-04-15

CRIT-LINE III Blood Chamber II

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K160749

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MRG 2016-04-15

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

Applicant Fujirebio Diagnostics,Inc.

K-Number K153361

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GEX 2016-04-15

SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber

Applicant Surgical Laser Incorporated

K-Number K151855

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MNR 2016-04-15

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal

Applicant Salter Labs

K-Number K151874

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