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

HTN 2017-11-08

SyndesMetrics Syndesmosis Repair System

Applicant Mortise Medical, LLC

K-Number K172620

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FMF 2017-11-08

MHC Standard and NRFit Tip Syringes

Applicant Mazza Healthcare, LLC

K-Number K171131

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PZO 2017-11-08

SurgicalPreview

Applicant Endo Vantage, LLC

K-Number K171534

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EFB 2017-11-08

Dental High-speed Turbine Handpiece

Applicant Guangdong Jinme Medical Technology Co., Ltd.

K-Number K170229

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OVD 2017-11-08

Idys™ ALIF System

Applicant Clariance, Sas

K-Number K172083

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GWM 2017-11-08

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit

Applicant Codman & Shurtleff, Inc.

K-Number K173192

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LLZ 2017-11-08

Surgical Planning Software version 1.1

Applicant Ortho Kinematics, Inc.

K-Number K173247

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PGY 2017-11-08

RadiForce RX560, RX560-AR

Applicant Eizo Corporation

K-Number K172738

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JEY 2017-11-08

Stryker Universal Mesh

Applicant Stryker

K-Number K170773

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JDR 2017-11-07

Compressyn™ Staple

Applicant Dallen Medical, Inc.

K-Number K171473

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FPA 2017-11-07

IV Administration Sets

Applicant B.Braun Medical, Inc.

K-Number K170595

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IYN 2017-11-07

UltraVision 2 Diagnostic Ultrasound System

Applicant Winprobe Corporation

K-Number K173265

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