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

FMI 2016-10-19

Advocate Insulin Pen Needles

Applicant Diabetic Supply of Suncoast, Inc.

K-Number K160199

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IYN 2016-10-19

Ultrasound System SONIMAGE HS1

Applicant Konica Minolta, Inc.

K-Number K162065

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DQD 2016-10-19

Tyto Stethoscope

Applicant Tyto Care , Ltd.

K-Number K160401

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GEI 2016-10-19

ReNew V Handpiece Laparoscopic Instruments

Applicant Microline Surgical, Inc.

K-Number K160706

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EIH 2016-10-19

ADAMANT ZIRCONIA DISC

Applicant Adamant Co., Ltd.

K-Number K160203

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LPN 2016-10-19

Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

Applicant Alcon Laboratories, Inc.

K-Number K162597

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DTE 2016-10-18

Medtronic Temporary External Pacemaker 53401

Applicant Medtronic, Inc.

K-Number K162054

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IYN 2016-10-18

NOBLUS Ultrasound Diagnostic System

Applicant Hitachi Medical Corporation

K-Number K160559

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MAX 2016-10-18

Rampart D Lumbar Interbody Fusion Device

Applicant Spineology, Inc.

K-Number K160074

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QEZ 2016-10-18

ClearLumen II Thrombectomy System

Applicant Walk Vascular, LLC

K-Number K161786

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PDQ 2016-10-18

Neuromonitoring Kit

Applicant SI-BONE, Inc.

K-Number K161893

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KLI 2016-10-18

VITROS® Automation Solutions

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K160495

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