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

MAX 2018-05-04

NuVasive® XLX Interbody System

Applicant Nu Vasive, Incorporated

K-Number K173892

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DXH 2018-05-04

QT ECG

Applicant QT Medical, Inc.

K-Number K180157

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PQH 2018-05-04

MEDRAD® Imaging Bulk Package Transfer Set

Applicant Bayer U.S., LLC

K-Number K173913

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OHV 2018-05-04

Ulthera System

Applicant Ulthera, Inc.

K-Number K180623

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MAX 2018-05-04

EVOL Spinal Interbody System, EVOS Lumbar Interbody System

Applicant Cutting Edge Spine, LLC

K-Number K180891

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MAX 2018-05-04

Hexanium® TLIF

Applicant Spinevision, S.A.S.

K-Number K180437

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LLZ 2018-05-04

Invenia ABUS Viewer

Applicant GE Healthcare

K-Number K180641

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HCG 2018-05-04

Wallaby Avenir Coil System

Applicant Wallaby Medical, Inc.

K-Number K173711

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NHA 2018-05-04

3.0 Dynamic TiBase

Applicant Talladium Espana, SL

K-Number K162021

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GYC 2018-05-04

g.Estim PRO

Applicant G.Tec Medical Engineering GmbH

K-Number K173684

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GAM 2018-05-04

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

Applicant Origami Surgical, LLC

K-Number K173874

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JIN 2018-05-04

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System

Applicant Taidoc Technology Corporation

K-Number K173345

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