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

MJH 2020-03-05

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

Applicant Ssi Diagnostica A/S

K-Number K191184

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QDQ 2020-03-05

Transpara

Applicant Screenpoint Medical B.V.

K-Number K193229

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ONF 2020-03-05

Lucent : IPL

Applicant Luvo Medical Technologies, Inc.

K-Number K193072

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PKL 2020-03-05

Instinct Plus Endoscopic Clipping Device

Applicant Cook Endoscopy

K-Number K192697

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FMF 2020-03-05

Omnifix Low Dead Space Luer Lock Syringe

Applicant B.Braun Medical, Inc.

K-Number K193101

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NDN 2020-03-05

V-STRUT Vertebral Implant

Applicant Hyprevention Sas

K-Number K191709

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NHA 2020-03-05

ATLANTIS Abutment for MIS Conical Connection Implants

Applicant Dentsply Sirona

K-Number K193529

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JAK 2020-03-05

CURA 778

Applicant Fmi Medical Systems, Inc.

K-Number K192590

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PJB 2020-03-05

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

Applicant Stereotaxis, Inc.

K-Number K193147

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MSD 2020-03-05

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters

Applicant C. R. Bard

K-Number K190527

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EBF 2020-03-05

Ezfil

Applicant Meta Biomed Co., Ltd.

K-Number K191991

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OWB 2020-03-05

TrackX

Applicant Track X Technology, LLC

K-Number K200360

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