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

LXB 2017-06-07

Cochlear Baha SoundArc

Applicant Cochlear Americas

K-Number K171088

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IZL 2017-06-07

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

Applicant Minxray, Inc.

K-Number K171353

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LNH 2017-06-07

Vantage Titan 1.5T, MRT-1510, M-Power GX

Applicant Toshibamedical Systems Corporation

K-Number K170412

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MHX 2017-06-06

EK12 Algorithm

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K170155

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IYN 2017-06-06

SonoBook Series Diagnostic Ultrasound System

Applicant Chison Medical Imaging Co., Ltd.

K-Number K170374

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PNL 2017-06-06

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K171429

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MML 2017-06-06

Altomed Malhotra Platinum Segments

Applicant Altomed Limited

K-Number K170591

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FLL 2017-06-06

Digital Thermometer

Applicant Guangzhou Jinxinbao Electronic Co., Ltd.

K-Number K163603

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OLI 2017-06-06

CURVE Laser System

Applicant Yolo Medical, Inc.

K-Number K170709

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IYO 2017-06-06

QT Ultrasound Breast Scanner-1

Applicant Qt Ultrasound, LLC

K-Number K162372

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HWC 2017-06-06

Flower Bone Screw Set

Applicant Flower Orthopedics Corporation

K-Number K170687

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NHA 2017-06-06

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System

Applicant Prismatik Dentalcraft, Inc.

K-Number K170044

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