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

DWJ 2019-05-02

Cocoon Convective Warming System

Applicant Care Essentials Pty, Ltd.

K-Number K181671

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NKB 2019-05-02

PASS LP Spinal System

Applicant Medicrea International SA

K-Number K190376

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MOF 2019-05-01

Synchro2 Support Guidewire

Applicant Stryker

K-Number K190843

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QPB 2019-05-01

VASERlipo System

Applicant Solta Medical

K-Number K190551

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CAP 2019-05-01

NS 120P-TRS Airway Pressure Gauge

Applicant Instrumentation Industries, Inc.

K-Number K180510

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QPB 2019-05-01

PowerX Lipo System

Applicant Solta Medical

K-Number K190555

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DXO 2019-05-01

TruWave Disposable Pressure Transducer

Applicant Edwards Lifeciences, LLC

K-Number K183413

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FDX 2019-05-01

Brush Biopsy Set ; Deflectable Brush Biopsy Set

Applicant Cook Incorporated

K-Number K182231

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GAT 2019-05-01

HS Fiber

Applicant Riverpoint Medical

K-Number K190817

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KWQ 2019-05-01

Boomerang Anterior Cervical Plate System

Applicant Choicespine, LP

K-Number K190227

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HQB 2019-05-01

Vitreq disposable laser probes, light fibers and Chandelier

Applicant VitreQ BV

K-Number K182646

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CCK 2019-05-01

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

Applicant GE Healthcare Finland Oy

K-Number K183394

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