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

FLL 2016-01-15

DISPOSABLE THERMOMETER PROBE SHEATHS

Applicant Pinghu Sama Medical Packing Co., Ltd.

K-Number K152690

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FDT 2016-01-15

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

Applicant Olympus Medical Systems Corp.

K-Number K143153

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EOB 2016-01-15

InstaClear Lens Cleaner

Applicant Gyrus Acmi, Inc.

K-Number K152531

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LLZ 2016-01-15

BR-ABVS Viewer 1.0

Applicant Taihao Medical, Inc.

K-Number K151075

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GEI 2016-01-15

Paragon T2 Wand with Integrated Cable

Applicant ArthroCare Corporation

K-Number K153675

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GDW 2016-01-15

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

Applicant Cardica, Inc.

K-Number K151081

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FRG 2016-01-15

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

Applicant Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std

K-Number K152669

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DSI 2016-01-15

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

Applicant Lifewatch Technologies , Ltd.

K-Number K151269

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LLZ 2016-01-15

HEALTHMYNE

Applicant Healthmyne, Inc.

K-Number K153289

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GEI 2016-01-15

Bovie Disposable Bipolar Ablator

Applicant Bovie Medical Corporation

K-Number K152777

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HKY 2016-01-15

Falck Medical Multifunction Tonometer, FAT1

Applicant Falck Medical, Inc.

K-Number K151491

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PLA 2016-01-15

Esophageal Cooling Device

Applicant Advanced Cooling Therapy, LLC

K-Number K152450

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