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

HSB 2018-08-24

Double Medical Femoral Nail System

Applicant Double Medical Technology, Inc.

K-Number K172830

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OVD 2018-08-24

NuVasive Brigade Lateral System

Applicant Nu Vasive, Incorporated

K-Number K181386

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NBW 2018-08-24

EasyMax BT Self-Monitoring Blood Glucose System

Applicant Eps Bio Technology Corp.

K-Number K182057

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BSO 2018-08-24

EPINAUT

Applicant Imedicom Co., Ltd.

K-Number K173541

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PGY 2018-08-24

RadiForce GX560, GX560-AR

Applicant Eizo Corporation

K-Number K181609

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NKB 2018-08-24

Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw

Applicant Orthofix, Inc.

K-Number K180179

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HRS 2018-08-24

AOS Small Fragment Plating System Lite

Applicant Advanced Orthopaedic Solutions, Inc. (Aos)

K-Number K181035

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HCC 2018-08-23

Freespira

Applicant Palo Alto Health Sciences, Inc.

K-Number K180173

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HIH 2018-08-23

MyoSure XL Tissue Removal Device for Fluent

Applicant Hologic, Inc.

K-Number K181974

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GGZ 2018-08-23

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K180186

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DFH 2018-08-23

Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

Applicant The Binding Site Group , Ltd.

K-Number K173732

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JWH 2018-08-23

GMK Sphere CR Tibial Inserts

Applicant Medacta International S.A.

K-Number K181635

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