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

LLZ 2018-02-23

DM-Density

Applicant Densitas, Inc.

K-Number K170540

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LNH 2018-02-23

SPIN-SWI

Applicant Spintech, Inc.

K-Number K173224

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OVE 2018-02-23

Cavetto-SA Cervical Cage System

Applicant Neurostructures, Inc.

K-Number K173077

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GEI 2018-02-23

Sutter CURIS RF Generator

Applicant Sutter Medizintechnik GmbH

K-Number K171869

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FLE 2018-02-23

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000

Applicant STERIS Corporation

K-Number K173493

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KWY 2018-02-23

ELEOS Bipolar Acetabular System

Applicant Onkos Surgical, Inc.

K-Number K180130

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IYN 2018-02-23

Ultrasound System 1300

Applicant Bk Medical Aps

K-Number K173569

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JAK 2018-02-23

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

Applicant Toshibamedical Systems Corporation

K-Number K173468

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LLZ 2018-02-23

Ez3D-i /E3

Applicant Ewoosoft Co., Ltd.

K-Number K173863

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LJE 2018-02-23

Ultraxx Nephrostomy Balloon Catheter

Applicant Cook Incorporated

K-Number K171601

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LZA 2018-02-22

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)

Applicant Koon Seng Sdn Bhd

K-Number K171171

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FLE 2018-02-22

Amsco Evolution Medium Steam Sterilizer

Applicant STERIS Corporation

K-Number K173485

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