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

LYC 2016-09-14

OSTEON III

Applicant Genoss Co., Ltd.

K-Number K153676

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OLO 2016-09-14

TSolution One Cup1 Surgical System

Applicant THINK Surgical, Inc.

K-Number K162195

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MOS 2016-09-14

dS FootAnkle I6CH 1.5T Coil

Applicant Invivo Corporation

K-Number K162177

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FRO 2016-09-14

Anexa Wound Flush, Sterile Water & Sterile Normal Saline

Applicant Anexa Biomedical, Inc.

K-Number K161658

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IYN 2016-09-14

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

Applicant Philips Health Care

K-Number K162329

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HAW 2016-09-14

StealthStation System with Cranial Software

Applicant Medtronic Navigation, Inc.

K-Number K153660

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DYB 2016-09-13

TXM Guiding Sheath

Applicant Texasmedical Technologies, Inc.

K-Number K153771

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DXO 2016-09-13

OptoMonitor II

Applicant Opsens, Inc.

K-Number K161263

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PBX 2016-09-13

TR-100

Applicant BTL Industries, Inc.

K-Number K161551

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EIH 2016-09-13

Initial LiSi Block

Applicant GC America, Inc.

K-Number K153130

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MAX 2016-09-12

JULIET® LL Lateral Lumbar Cage

Applicant Spineart

K-Number K161888

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EIH 2016-09-12

Pavati Z40.2 Zirconia

Applicant Ccri, Inc.

K-Number K160867

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