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

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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NKB 2017-05-25

SETx Pedicle Screw System

Applicant Xenco Medical, LLC

K-Number K170611

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OWN 2017-05-25

KARL STORZ ICG Imaging System

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K171238

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LDF 2017-05-25

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead

Applicant Medtronic

K-Number K171253

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PGY 2017-05-25

LCD Monitor (MD310C, MD310G, MD210G)

Applicant Benq Corporation

K-Number K170944

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NHA 2017-05-25

TruAbutment DS

Applicant Truabutment

K-Number K170259

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OOI 2017-05-25

revogene

Applicant Genepoc, Inc.

K-Number K170558

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