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

NAY 2020-03-09

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K200049

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OEB 2020-03-09

syngo.CT Lung CAD

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K193216

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GEX 2020-03-09

Elite iQ

Applicant Cynosure, LLC

K-Number K193426

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PRI 2020-03-09

Elecsys BRAHMS PCT

Applicant Roche Diagnostics

K-Number K192815

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QBP 2020-03-06

SwabTip Male Disinfectant Cap

Applicant Icu Medical

K-Number K190918

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HTY 2020-03-06

OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant

Applicant OSSIO , Ltd.

K-Number K190652

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DBF 2020-03-06

Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

Applicant HORIBA ABX SAS

K-Number K191562

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DWA 2020-03-06

CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

Applicant Abbott (Formerly Thoratec Corporation)

K-Number K200306

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IYN 2020-03-06

EPIQ Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K200304

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PFW 2020-03-06

sam 2.0 Long Duration Ultrasound System

Applicant ZetrOZ Systems, LLC

K-Number K191568

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KGO 2020-03-06

SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V

Applicant Medline Industries, Inc.

K-Number K191915

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MXZ 2020-03-06

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).

Applicant Leica Biosystems Newcastle, Ltd.

K-Number K193393

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