Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

QIH 2022-08-29

Viz RV/LV

Applicant Viz. Ai, Inc.

K-Number K221100

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FOZ 2022-08-29

Leaderflex Mini and Leaderflex Nano

Applicant Vygon USA

K-Number K212370

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NBW 2022-08-29

GlucoLeader Enhance 2 Blood Glucose Monitoring System

Applicant Hmd Biomedical, Inc.

K-Number K212248

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DXN 2022-08-29

Blood Pressure Monitor

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K220676

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LZC 2022-08-27

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K222449

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PML 2022-08-26

BonOs® Inject Bone Cement; NEO Pedicle Screw System™

Applicant Neo Medical SA

K-Number K222256

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FGB 2022-08-26

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K220159

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GZJ 2022-08-26

StimOnTM Pain Relief System (GM2439)

Applicant Gimer Medical Co., Ltd.

K-Number K213802

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JWH 2022-08-26

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

Applicant Corentec Co., Ltd.

K-Number K222278

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DXN 2022-08-26

Upper Arm Blood Pressure Monitor

Applicant Shenzhen Yolanda Technology Co., Ltd.

K-Number K221212

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PRI 2022-08-26

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K220262

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QAS 2022-08-26

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K222277

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