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

PKR 2017-12-07

gammaCore-2

Applicant Eletrocore, LLC

K-Number K172270

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FDI 2017-12-07

Single Use Electrosurgical Snare SD-400

Applicant Olympus Medical Systems Corp.

K-Number K172734

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GCJ 2017-12-07

Equipment Pouch

Applicant Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

K-Number K172578

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KGN 2017-12-07

gel-e Bandage

Applicant Gel-E, Inc. (Formerly Remedium Technologies, Inc.)

K-Number K172010

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DQX 2017-12-07

Lunderquist Extra Stiff Wire Guide

Applicant William Cook Europe Aps

K-Number K171513

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PBJ 2017-12-07

Craniomaxillofacial Distraction System (CMFD)

Applicant Synthes USA Products, LLC

K-Number K170818

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IYN 2017-12-07

Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K-Number K173000

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GEX 2017-12-07

Q-Switched Nd:YAG Laser System

Applicant Ami, Inc.

K-Number K172908

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OWI 2017-12-07

NuVasive® VersaTie™ System

Applicant Nuvasive, Inc.

K-Number K173117

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FAJ 2017-12-07

Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

Applicant Henke-Sass, Wolf GmbH

K-Number K171336

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LJS 2017-12-06

C3 Wave System

Applicant Medical Components, Inc (Dba Medcomp_

K-Number K170934

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HRS 2017-12-06

OrthoPediatrics Wrist Fusion Plate

Applicant Orthopediatrics, Inc.

K-Number K172425

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