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

JAK 2017-12-07

NeuViz 16 Essence Multi-slice CT Scanner System

Applicant Neusoft Medical Systems Co., Ltd.

K-Number K171198

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LTT 2017-12-07

MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K172912

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LZO 2017-12-07

MasterLoc Stem: Lateralized Plus

Applicant Medacta International S.A.

K-Number K173267

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IYO 2017-12-07

Lilium a-200E

Applicant Lilium Otsuka Co., Ltd.

K-Number K170046

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HSB 2017-12-07

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

Applicant Orthofix Srl

K-Number K173458

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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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