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

JOW 2017-07-11

Devon 24

Applicant Devon Medical Products (Jiangsu), Ltd.

K-Number K170814

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IYN 2017-07-11

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

Applicant Supersonic Imagine

K-Number K171105

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MQE 2017-07-11

Kitazato OPU Needles

Applicant Kitazato Corporation

K-Number K162881

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SEL 2017-07-11

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

Applicant 3M Company

K-Number K171908

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IYN 2017-07-10

M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System

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

K-Number K171034

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FTM 2017-07-10

Biodesign Parastomal Hernia Repair Graft

Applicant Cook Biotech Incorporated

K-Number K162934

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LZA 2017-07-10

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs

Applicant Kossan International Sdn Bhd

K-Number K170397

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FMI 2017-07-10

Mini Needle

Applicant Ocuject, LLC

K-Number K170768

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NGX 2017-07-10

XiniWave II Model ECS322P

Applicant International Trade Group, Inc.

K-Number K171092

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MHJ 2017-07-10

TRI-COMBO PARASITE SCREEN

Applicant Techlab, Inc.

K-Number K171078

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GEX 2017-07-07

Thunder, Thunder VT, Thunder HR

Applicant Quanta System Spa

K-Number K171711

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NPM 2017-07-07

Anorganic Bone Mineral in Delivery Applicator

Applicant Collagen Matrix, Inc.

K-Number K170541

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