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

OWB 2018-08-17

SmartPerfusion

Applicant Philips Medical Systems Nederlands B.V.

K-Number K181966

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DXT 2018-08-17

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

Applicant Bayer Medical Care, Inc.

K-Number K173773

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LJE 2018-08-17

Ultraxx Nephrostomy Balloon Catheter Set

Applicant Cook Incorporated

K-Number K181713

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LZA 2018-08-17

Biodegradable Nitrile Powder Free Examination Glove (Blue)

Applicant Hartalega Sdn Bhd

K-Number K173509

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MNR 2018-08-17

Watch-PAT300

Applicant Itamar Medical , Ltd.

K-Number K180775

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BWF 2018-08-17

VersaPAP Positive Airway Pressure (PAP) Device

Applicant Trudell Medical International

K-Number K173918

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FRO 2018-08-17

Simple Science Antimicrobial Facial and Eyelid Cleanser

Applicant Simple Science, LLC

K-Number K181074

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OHP 2018-08-16

Bongo

Applicant Innomed Healthscience, Inc.

K-Number K180619

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FAJ 2018-08-16

Luminelle DTx Hysteroscopy System

Applicant Uvision360, Inc.

K-Number K181909

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KPS 2018-08-16

NeuroQ 3.8

Applicant Syntermed

K-Number K180077

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LLZ 2018-08-16

IGTFusion

Applicant Igi Technologies

K-Number K180522

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GBM 2018-08-16

GentleCath Glide Intermittent Urinary Catheter

Applicant Convatec Limited

K-Number K181206

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