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

HKI 2018-12-10

LipiScan Dynamic Meibomian Imager

Applicant Tearscience, Inc.

K-Number K182506

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GEX 2018-12-10

SabreLine and SabreGuard Laser Fibers

Applicant Coloplast Corp.

K-Number K182831

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HRS 2018-12-10

Distal Radius Plating System

Applicant Miami Device Solutions, LLC

K-Number K182810

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JFY 2018-12-10

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

Applicant Yd Diagnostics Corporation

K-Number K182038

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DQY 2018-12-10

Route 92 Medical Delivery Catheter

Applicant Route 92 Medical, Inc.

K-Number K182512

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JOJ 2018-12-10

CelerityTM 10 STEAM Chemical Indicator

Applicant STERIS Corporation

K-Number K182724

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LON 2018-12-10

VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

Applicant bioMerieux, Inc.

K-Number K181766

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DJG 2018-12-10

ARK Tramadol Assay

Applicant Ark Diagnostics, Inc.

K-Number K182280

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MHX 2018-12-10

BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K182075

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GEI 2018-12-10

LUTRONIC GENIUS Radiofrequency System

Applicant Lutronic Corporation

K-Number K180945

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FLL 2018-12-10

Disposable Temperature Probe

Applicant Shenzhen Launch Electrical Co., Ltd.

K-Number K181967

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FRO 2018-12-10

Procellera Composite Antibacterial Wound Dressing

Applicant Vomaris Wound Care, Inc.

K-Number K180533

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