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

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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NDC 2017-11-07

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K-Number K172177

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HSN 2017-11-07

Hintermann Series H2 Total Ankle System

Applicant Dt Medtech, LLC

K-Number K171004

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DRG 2017-11-07

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Applicant Rooti Labs , Ltd.

K-Number K163694

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