Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MWI 2017-05-26

T3 Software

Applicant Etiometry, Inc.

K-Number K163065

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OYH 2017-05-26

AcceleDent Optima

Applicant Orthoaccel Technology, Inc.

K-Number K170093

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JOW 2017-05-26

Flexitouch System

Applicant Tactile Systems Technology, Inc. (Dba Tactile Medical)

K-Number K170216

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NEZ 2017-05-26

RAPID Web

Applicant Given Imaging , Ltd.

K-Number K170839

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OWB 2017-05-26

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

Applicant Gemss Medical Systems Co., Ltd.

K-Number K163140

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CGL 2017-05-26

Nova StatSensor Creatinine Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K171059

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NAY 2017-05-26

da Vinci X Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K171294

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PQM 2017-05-26

Ultravision Visual Field Clearing System

Applicant Alesi Surgical, Ltd.

K-Number K170178

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DXT 2017-05-26

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System

Applicant Osprey Medical, Inc.

K-Number K171217

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NDC 2017-05-26

My Dose Coach

Applicant Sanofi

K-Number K171230

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DQO 2017-05-26

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter

Applicant Cook Incorporated

K-Number K162448

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JWY 2017-05-25

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K170892

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