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

HRS 2021-07-16

Avanti Orthopaedics Ulnar Shortening System

Applicant Avanti Orthopaedics, Inc.

K-Number K211592

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FPA 2021-07-16

Medtronic Extended infusion set

Applicant Unomedical A/S

K-Number K210544

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OVE 2021-07-16

SureMAX-SA Cervical Standalone System

Applicant Additive Implants, Inc.

K-Number K211111

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KXT 2021-07-16

ADVIA Centaur® Digoxin assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K193397

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MHX 2021-07-16

Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System

Applicant Nihon Kohden Corporation

K-Number K203435

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FMF 2021-07-16

SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX

Applicant Lifelong Meditech Private Limited

K-Number K210103

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QBJ 2021-07-15

Dexcom G6 Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K201328

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KKY 2021-07-15

Longeviti PorousFit implant

Applicant Longeviti Neuro Solutions, LLC

K-Number K211514

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JOJ 2021-07-15

Crosstex VH2O2 Chemical Indicators

Applicant Crosstex International, Inc. (A Cantel Medical Company)

K-Number K200096

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DWF 2021-07-15

Bio-Medicus Life Support Catheter and Introducer

Applicant Medtronic, Inc.

K-Number K201100

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FXX 2021-07-15

Disposable Procedural Ear-loop Face Mask

Applicant Changzhou Dsb Medical Co., Ltd.

K-Number K211042

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NGX 2021-07-15

Pain Therapy Device

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K202638

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