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

QAS 2020-03-18

Viz ICH

Applicant Viz. Ai, Inc.

K-Number K193658

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NTE 2020-03-18

WIRION

Applicant Cardiovascular Systems, Inc.

K-Number K200198

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MAI 2020-03-18

HEALICOIL Knotless Suture Anchors

Applicant Smith & Nephew, Inc.

K-Number K193558

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BSZ 2020-03-18

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

Applicant Maquet Critical Care AB

K-Number K191027

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LTT 2020-03-18

MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K193536

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DQY 2020-03-18

speX LP Support Catheter

Applicant Reflow Medical

K-Number K200094

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PNV 2020-03-18

PulmoScan

Applicant Cognita Labs, LLC

K-Number K191876

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KTI 2020-03-18

ViziShot 2 FLEX

Applicant Olympus Surgical Technologies America

K-Number K193517

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HGX 2020-03-18

Evolve Breast Pump

Applicant Hygeia II Medical Group, Inc.

K-Number K200406

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MQB 2020-03-18

VIVIX-S VW

Applicant Vieworks Co., Ltd.

K-Number K200418

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MBH 2020-03-18

LINK TrabecuLink Tibial Cones

Applicant Waldemar Link GmbH & Co. KG

K-Number K200113

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PEN 2020-03-18

BioFire Blood Culture Identification 2 (BCID2) Panel

Applicant Biofire Diagnostics, LLC

K-Number K193519

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