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

GWN 2016-04-26

ISEN-Goggles

Applicant Isen Tech & Trading Company, Ltd.

K-Number K152727

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DJG 2016-04-26

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

Applicant Co-Innovation Biotech Co., Ltd.

K-Number K153050

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NKB 2016-04-26

Inertia Pedicle Screw and Deformity Correxxion System

Applicant Nexxt Spine, LLC

K-Number K153453

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MAX 2016-04-26

Genesys Spine Apache Interbody Fusion System

Applicant Genesys Spine

K-Number K153123

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IYN 2016-04-26

Voluson P6, Voluson P8

Applicant GE Healthcare

K-Number K160162

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JCX 2016-04-25

Stryker Neptune 3 Waste Management System

Applicant Stryker Corporation

K-Number K153407

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DZE 2016-04-25

maxFit II Dental Implant System

Applicant Taiwan Implant Technology Company, Ltd.

K-Number K151588

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OAP 2016-04-25

Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202

Applicant Capillus, LLC

K-Number K160285

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LLZ 2016-04-25

MIM-Thin Client (mobile)

Applicant Mim Software, Inc.

K-Number K151913

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NBW 2016-04-25

POGO Automatic Blood Glucose Monitoring System

Applicant Intuity Medical, Inc.

K-Number K152493

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PNI 2016-04-25

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

Applicant Kronus, Inc.

K-Number DEN150030

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LIT 2016-04-25

MMS PTA Balloon Catheter

Applicant Micro Medical Solutions, Inc.

K-Number K152934

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