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

KNW 2016-07-19

EnCor MRI Introducer Set, EnCor Probe Introducer

Applicant Senorx, Inc.

K-Number K161805

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MQG 2016-07-18

RI Witness Embryology Heated Plate

Applicant Research Instruments Limited

K-Number K160504

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CHL 2016-07-15

EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control

Applicant Edan Instruments, Inc.

K-Number K151978

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IZH 2016-07-15

Comfort Cover

Applicant Precision Dynamics Corporation

K-Number K161920

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MAX 2016-07-15

Juliet® Ti

Applicant Spineart

K-Number K153621

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DQD 2016-07-15

Steth IO

Applicant Stratoscientific, Inc.

K-Number K160016

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PNA 2016-07-15

EPIC ClearView System

Applicant Epic Research & Diagnostics, Inc.

K-Number DEN150004

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DSH 2016-07-15

myPatch-s

Applicant Dms-Service, LLC

K-Number K160704

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OWI 2016-07-15

NuVasive® VersaTie System

Applicant Nu Vasive, Incorporated

K-Number K161265

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DYB 2016-07-15

FlexSeal Introducer Sheath with Hydrophilic Coating

Applicant Libramedical, Inc.

K-Number K161659

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KPR 2016-07-15

FDR Visionary Suite

Applicant Shimadzu Corporation

K-Number K152294

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ODP 2016-07-15

Ascential IBD PEEKc Spacer

Applicant Stryker Spine

K-Number K161407

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