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

LZO 2016-03-10

OMNI Skirted Heads

Applicant Omni Life Science, Inc.

K-Number K152919

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CCK 2016-03-10

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

Applicant Salter Labs

K-Number K151421

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GWO 2016-03-10

PEEK Customized Cranial Implant

Applicant Stryker

K-Number K153248

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LZA 2016-03-10

Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color

Applicant Xingda Medical Products Co., Ltd.

K-Number K152720

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KRA 2016-03-09

MMS Guide Catheter

Applicant Micro Medical Solutions, Inc.

K-Number K152625

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LZA 2016-03-09

Nitrile Powder Free Patient Examination Gloves, Blue Color

Applicant Zhonghong Pulin Medical Products Co., Ltd.

K-Number K152712

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HRS 2016-03-09

Piccolo Composite(R) Distal Volar Radius Plate System

Applicant CarboFix Orthopedics , Ltd.

K-Number K160002

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HTY 2016-03-09

S-Wire

Applicant Spinal Resources, Inc.

K-Number K152662

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KGO 2016-03-09

Gammex PI Hybrid Surgical Gloves

Applicant Ansell Healthcare Products, LLC

K-Number K151694

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JAK 2016-03-09

SmartView 3D Option

Applicant Ge Hangwei Medical System Co., Ltd.

K-Number K153429

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GEX 2016-03-09

Family of CoolGlide Aesthetic Lasers

Applicant Cutera, Inc.

K-Number K153671

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IYN 2016-03-09

TE7 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K160381

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