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

DZE 2017-06-13

Deep Conical (DC) Implants and Accessories

Applicant Southern Implants (Pty), Ltd.

K-Number K163060

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MQG 2017-06-13

COOK Vacuum Pump

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K160753

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GEI 2017-06-13

SECRET RF

Applicant Ilooda Co,., Ltd.

K-Number K170325

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LOX 2017-06-12

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

Applicant B. Braun Interventional Systems, Inc.

K-Number K162625

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MAX 2017-06-12

SPIRA Open Matrix ALIF

Applicant Camber Spine Technologies

K-Number K162986

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MQB 2017-06-12

1417WGC_127um and 1417WGC_140um

Applicant Rayence Co., Ltd.

K-Number K171417

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IYO 2017-06-12

MELODY, Remote Control System for Ultrasound Probe

Applicant Adecho Tech

K-Number K161354

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GEX 2017-06-12

Picocare

Applicant Wontech Co., Ltd.

K-Number K162755

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IYN 2017-06-12

SonoSite X-Porte Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K171437

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NKB 2017-06-12

Iliad® Pedicle Screw System and Zenius® Pedicle Screw System

Applicant Medyssey USA, Inc.

K-Number K171509

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MQB 2017-06-12

1417WCC_127um and1417WCC_140um

Applicant Rayence Co., Ltd.

K-Number K171418

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IYN 2017-06-12

Vivid E80, Vivid E90, Vivid E95

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K170823

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