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

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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PGM 2017-11-06

NuVasive® Growth Rod Conversion Set

Applicant Nu Vasive, Incorporated

K-Number K172979

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LZA 2017-11-06

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K172442

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HRS 2017-11-06

Omni Foot Plating System

Applicant Extremity Medical, LLC

K-Number K172260

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