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

GXY 2018-11-29

Espire Elbow Pro, Espire Elbow Hybrid

Applicant College Park Industries, Inc.

K-Number K182757

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DQA 2018-11-29

AS-3XX Series Fingertip Pulse Oximeter

Applicant Xiamen Acurio Instruments Co., Ltd.

K-Number K180685

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OMB 2018-11-29

Persyst 14 EEG Review and Analysis Software

Applicant Persyst Development Corporation

K-Number K182181

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EIH 2018-11-29

Ceramic Denture Zirconia Ceramics Block

Applicant Qinhuangdao Silide Ceramic Technology Co., Ltd.

K-Number K181816

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BTR 2018-11-29

VivaSight-SL (TVT) system

Applicant Etview , Ltd.

K-Number K181880

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NBW 2018-11-29

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System

Applicant Tyson Bioresearch, Inc.

K-Number K182047

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PCH 2018-11-29

BD MAX Enteric Viral Panel, BD MAX Instrument

Applicant Becton, Dickinson and Company

K-Number K181427

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NBW 2018-11-28

BGM014 Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K182992

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LZO 2018-11-28

SMS Femoral Stem

Applicant Medacta International S.A.

K-Number K181693

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ELW 2018-11-28

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

Applicant Hrs Co., Ltd.

K-Number K181604

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MQP 2018-11-28

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

Applicant K2m, LLC

K-Number K180665

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GDW 2018-11-28

AEON Endoscopic Stapler

Applicant Lexington Medical, Inc.

K-Number K182380

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