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

LJS 2017-10-26

Celerity ECG Cable Accessory Pack

Applicant Medcomp (Medical Components, Inc.)

K-Number K171931

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LLZ 2017-10-26

OrthoVision

Applicant Ewoosoft Co., Ltd.

K-Number K173094

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MUH 2017-10-26

Cocoon Portable Handheld X-Ray System

Applicant Dexcowin Co., Ltd.

K-Number K173046

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NHA 2017-10-26

Healing Cap Multi-Unit Titanium

Applicant Nobel Biocare AB

K-Number K171142

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MAX 2017-10-26

NuVasive® Modulus TLIF Interbody System

Applicant Nu Vasive, Incorporated

K-Number K172341

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OWI 2017-10-26

SILC® Fixation System

Applicant Globus Medical, Inc.

K-Number K172417

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MAX 2017-10-26

SeaSpine Ventura NanoMetalene System

Applicant SeaSpine Orthopedics Corporation

K-Number K173022

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KRD 2017-10-25

Gel-Bead

Applicant Vascular Solutions, Inc.

K-Number K171946

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IYN 2017-10-25

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K172970

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DIO 2017-10-25

Emit II Plus Cocaine Metabolite Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K170293

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NKB 2017-10-25

VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations

Applicant Medos International SARL

K-Number K173095

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NKB 2017-10-25

CosmoLock Pedicle Screw System

Applicant Kalitec Direct, LLC

K-Number K172808

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