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

HGX 2018-11-30

Spectra S3 Plus

Applicant Uzinmedicare Co.

K-Number K181784

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BZD 2018-11-30

Transcend 365 miniCPAP System

Applicant Somnetics International, Inc.

K-Number K180388

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OAS 2018-11-30

Planmed Verity

Applicant Planmed OY

K-Number K180918

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KPS 2018-11-30

SubtlePET

Applicant Subtle Medical, Inc.

K-Number K182336

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DXN 2018-11-30

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System

Applicant Edwards Lifesciences, LLC

K-Number K182245

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GMQ 2018-11-30

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

Applicant Arlington Scientific, Inc. (Asi)

K-Number K182391

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LYA 2018-11-30

ChitoZolve

Applicant Gyrus Acmi, Inc.

K-Number K181696

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BTA 2018-11-29

Thoraguard System

Applicant Centese, Inc.

K-Number K181667

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GEI 2018-11-29

Device Electrosurgical Generator ESG-150

Applicant Olympus Winter & Ibe GmbH

K-Number K182587

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DZE 2018-11-29

Implant-One System

Applicant Implant Logistics, Inc.

K-Number K173701

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PDJ 2018-11-29

Afinion HbA1c Dx on Afinion 2

Applicant Alere Technologies AS

K-Number K182988

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KWQ 2018-11-29

V3 Segmental Plating System

Applicant Atlas Spine, Inc.

K-Number K182418

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