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

QFG 2019-02-14

t:slim X2 insulin pump with interoperable technology

Applicant Tandem Diabetes Care, Inc.

K-Number DEN180058

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OLO 2019-02-14

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker

Applicant Stryker Corporation

K-Number K183196

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FRO 2019-02-14

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing

Applicant Winner Medical Co., Ltd.

K-Number K181315

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DXN 2019-02-14

GMC Wrist Automatic Blood Pressure Monitor

Applicant Gmc, Inc.

K-Number K181930

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EOQ 2019-02-14

Ion Endoluminal System ; Flexision Biopsy Needle

Applicant Intuitive Surgical

K-Number K182188

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LZO 2019-02-14

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

Applicant B-One Ortho, Corp.

K-Number K182705

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LNH 2019-02-14

MAGNETOM Amira, MAGNETOM Sempra

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183221

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MAI 2019-02-14

HEALIX ADVANCE Anchor with DYNACORD Suture

Applicant Medos International SARL

K-Number K183506

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HRS 2019-02-14

AdvantageRib System

Applicant Sig Medical Corporation

K-Number K183317

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LLZ 2019-02-14

Presero 3D Scanning System

Applicant Certis Health

K-Number K190074

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EIH 2019-02-14

DD cube ONE ML

Applicant Dental Direkt GmbH

K-Number K183569

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PSQ 2019-02-14

PhotoFix Decellularized Bovine Pericardium

Applicant Cryolife, Inc.

K-Number K183635

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