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

NAY 2018-04-23

da Vinci Xi Surgical System, da Vinci X Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K173842

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DRG 2018-04-23

Patient Status Engine

Applicant Isansys Lifecare, Ltd.

K-Number K172329

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LKM 2018-04-23

Sysmex UF-5000 Fully Automated Urine Particle Analyzer

Applicant Sysmex America, Inc.

K-Number K171883

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HSB 2018-04-23

Agile Nail

Applicant Orthofix Srl

K-Number K172699

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MTD 2018-04-23

Advisor HD Grid Mapping Catheter, Sensor Enabled

Applicant St. Jude Medical, Inc.

K-Number K172393

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PHX 2018-04-20

Arthrex Univers Revers Modular Glenoid System

Applicant Arthrex, Inc.

K-Number K173900

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KGI 2018-04-20

Aria

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K180782

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GEX 2018-04-20

Etherea MX

Applicant Vydence Medical Industria E Comercio Ltda

K-Number K171443

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NHA 2018-04-20

Neodent Implant System GM Line

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K173902

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LJS 2018-04-20

Hickman TriFusion Catheter

Applicant C.R. Bard, Inc.

K-Number K172511

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KTL 2018-04-20

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

Applicant Euroimmun Us, Inc.

K-Number K172244

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KTL 2018-04-20

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

Applicant Euroimmun Us, Inc.

K-Number K172252

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