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

OUR 2017-01-18

Siconus SI Joint Fixation System

Applicant Camber Spine Technologies

K-Number K162121

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HQD 2017-01-18

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K163254

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HBG 2017-01-18

Taps for Resorbable Screws

Applicant Synthes (USA) Products, LLC

K-Number K153587

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DSA 2017-01-18

Multi-Link X2 ECG Cable and Lead Wire System

Applicant Carefusion 2200, Inc.

K-Number K162432

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GCJ 2017-01-18

EndoClot

Applicant Endoclot Plus Co., Ltd.

K-Number K162197

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PBF 2017-01-18

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

Applicant Materialise NV

K-Number K163156

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BZD 2017-01-18

F&P Brevida Nasal Pillows Mask

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K161412

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QSY 2017-01-18

Bondiloxs Topical Hemostatic Granules

Applicant Medtrade Products , Ltd.

K-Number K161274

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HWC 2017-01-18

GEO Bone Screw System

Applicant Gramercy Extremity Orthopeidics, LLC

K-Number K161904

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GZJ 2017-01-18

STIMPOD NMS460 Nerve Stimulator

Applicant Xavant Technology (Pty), Ltd.

K-Number K161091

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MOS 2017-01-18

Breast BI 7 MR Coil Mammavention 3T

Applicant Moras Mri Products GmbH

K-Number K162651

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MMI 2017-01-18

Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5

Applicant Roche Diagnostics

K-Number K162895

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