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

HSN 2017-02-22

PROPHECY INVISION Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K-Number K162795

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DSH 2017-02-22

my Patch sl

Applicant Dms-Service, LLC

K-Number K163535

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HAW 2017-02-22

Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

Applicant Stryker Corporation

K-Number K162929

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JWY 2017-02-22

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

Applicant Liofilchem s.r.l.

K-Number K163298

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NGX 2017-02-22

BEMER Classic Set, BEMER Pro-Set

Applicant Bemer Int AG

K-Number K151834

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LZA 2017-02-22

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E

Applicant Pt. Medisafe Technologies

K-Number K163041

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EKX 2017-02-22

MEG-TORQ

Applicant Micro-Nx Co., Ltd.

K-Number K161500

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GEX 2017-02-22

ND YAG Q-switch Laser Therapy Machine

Applicant Beijing Adss Development Co., Ltd.

K-Number K161926

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MQB 2017-02-22

Aquarius 8600

Applicant Imaging Dynamics Company , Ltd.

K-Number K170202

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GQG 2017-02-22

Sofia RSV FIA on Sofia 2 analyzer

Applicant Quidel Corporation

K-Number K162911

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BTY 2017-02-22

EasyOne Pro Respiratory Analysis System

Applicant Ndd Medizintechnik AG

K-Number K161534

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MAX 2017-02-22

SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer

Applicant Globus Medical, Inc.

K-Number K152022

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