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

NEZ 2018-11-08

MiroCam Capsule Endoscope System

Applicant Intromedic Co., Ltd.

K-Number K180732

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LYZ 2018-11-07

Powder Free Vinyl Patient Examination Gloves

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K180381

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PQX 2018-11-07

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

Applicant Certa Dose, Inc.

K-Number K180683

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NJR 2018-11-07

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

Applicant Diasorin Molecular, LLC

K-Number K182467

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LLZ 2018-11-07

uWS-CT

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K173001

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DSA 2018-11-07

Curbell branded Patient Monitoring Cables

Applicant Curbell Medical Products, Inc.

K-Number K182220

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LLZ 2018-11-07

uWS-MR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K172999

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KLE 2018-11-07

OptiBond eXTRa Universal

Applicant Kerr Corporation

K-Number K182162

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FMF 2018-11-06

Merit Syringe

Applicant Merit Medical Systems, Inc.

K-Number K182279

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DZE 2018-11-06

W Zirconia Implants

Applicant Tav Medical , Ltd.

K-Number K172668

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IYN 2018-11-06

Vivid T8, Vivid T9

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K181934

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FMF 2018-11-06

Merit Syringe

Applicant Merit Medical Systems, Inc.

K-Number K182216

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