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

NDC 2017-11-07

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K-Number K172177

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HSN 2017-11-07

Hintermann Series H2 Total Ankle System

Applicant Dt Medtech, LLC

K-Number K171004

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DRG 2017-11-07

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Applicant Rooti Labs , Ltd.

K-Number K163694

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LPL 2017-11-07

NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Applicant Visioneering Technologies, Inc.

K-Number K173086

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LQR 2017-11-07

NCompass Nitinol Stone Extractors

Applicant Cook Incorporated

K-Number K173009

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MAX 2017-11-07

Lateral Spinal Truss System (LSTS) Interbody Fusion Device

Applicant 4Web, Inc.

K-Number K172392

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MBH 2017-11-07

Arthrex Knee Systems

Applicant Arthrex, Inc.

K-Number K171365

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ODP 2017-11-07

SPIRA-C Open Matrix Cervical Interbody

Applicant Camber Spine Technologies

K-Number K172446

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NBW 2017-11-07

StatStrip Xpress Blood Glucose Monitoring System

Applicant Nova Biomedical Corporation

K-Number K170464

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DZE 2017-11-06

External Hex Implants

Applicant Southern Implants (Pty), Ltd.

K-Number K163634

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FMK 2017-11-06

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

Applicant Gri Medical & Electronic Technology Co., Ltd.

K-Number K172712

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GKZ 2017-11-06

XW-100 Automated Hematology Analyzer for CLIA Waived Use

Applicant Sysmex America, Inc.

K-Number K172604

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