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

MWI 2018-05-25

STAR 65

Applicant Skanray Technologies Pvt, Ltd.

K-Number K172147

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FLL 2018-05-25

Infrared Thermometer

Applicant Shenzhen Pacom Medical Instruments Co., Ltd.

K-Number K172889

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KGN 2018-05-25

SURECELL Gelling Fiber Wound Dressing

Applicant Jiangsu Newvalue Medical Producst Co.,Ltd

K-Number K173005

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DTQ 2018-05-25

Quantum Pump Console

Applicant Spectrum Medical , Ltd.

K-Number K173834

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HQF 2018-05-25

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

Applicant Topcon Medical Laser Systems, Inc.

K-Number K180402

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PEH 2018-05-25

ClearGuard HD Antimicrobial Barrier Cap

Applicant Pursuit Vascular, Inc.

K-Number K180111

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JIL 2018-05-25

inui In-Home Urine Analysis Test System

Applicant Scanadu, Inc.

K-Number K180356

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FCX 2018-05-25

FUJIFILM Endoscopic CO2 Regulator GW-100

Applicant Fujifilm Corporation

K-Number K180711

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FKX 2018-05-24

Fresenius Liberty Select Cycler

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K181108

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JEY 2018-05-24

GBR system

Applicant Surgident

K-Number K170697

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LEL 2018-05-24

ActiGraph CentrePoint Insight Watch

Applicant Actigraph

K-Number K181077

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KNW 2018-05-24

Celling Aspiration Needle

Applicant Spine Smith Holdings, LLC

K-Number K180807

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