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

JGS 2020-04-14

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K200403

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LLZ 2020-04-14

Xelis Dental 2.0

Applicant Infinitt Healthcare Co., Ltd.

K-Number K193369

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QAS 2020-04-13

CuraRad-ICH

Applicant Curacloud Corp.

K-Number K192167

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KFM 2020-04-13

Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

Applicant Qura S.R.L

K-Number K192850

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GEX 2020-04-13

ND:YAG Laser

Applicant Beijing Superlaser Technology Co., Ltd.

K-Number K193464

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DHX 2020-04-13

ADVIA Centaur CEA Assay

Applicant Siemens Healthcare Disgnostics, Inc.

K-Number K200215

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DZE 2020-04-13

s-Clean SQ-SL Implant System Mini

Applicant Dentis Co., Ltd.

K-Number K200099

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DWA 2020-04-13

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

Applicant Spectrum Medical , Ltd.

K-Number K192838

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GEI 2020-04-13

VivAer Stylus

Applicant Aerin Medical, Inc.

K-Number K200300

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IZL 2020-04-13

AcuityPDR

Applicant Radmedix, LLC

K-Number K200726

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ONN 2020-04-12

VERASENSE for Stryker Triathlon

Applicant Orthosensor, Inc.

K-Number K200665

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IPF 2020-04-11

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K-Number K193275

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