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 2016-04-04

Opticage(R) Expandable Interbody Fusion Device

Applicant Interventional Spine, Inc.

K-Number K160464

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IYN 2016-04-04

Acclarix LX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K160790

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HSB 2016-04-04

PRECICE Intramedullary Limb Lengthening System

Applicant Ellipse Technologies, Inc.

K-Number K160325

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LZA 2016-04-04

HG Pro Nitrile Powder Free Examination Gloves

Applicant Healthy Glove Co., Ltd.

K-Number K152479

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MNI 2016-04-04

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

Applicant Spinevision S.A.

K-Number K160124

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NGT 2016-04-04

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

Applicant Becton, Dickinson and Company

K-Number K153481

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IYN 2016-04-04

S45 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K160283

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MSD 2016-04-04

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

Applicant Merit Medical Systems, Inc.

K-Number K151967

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NBW 2016-04-01

TRUE METRIX GO Self Monitoring Blood Glucose System

Applicant Trividia Health, Inc.

K-Number K143548

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DQK 2016-04-01

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

Applicant Spacelabs Healthcare, Ltd.

K-Number K152881

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IZH 2016-04-01

Affirm Prone Biopsy System

Applicant Hologic, Inc.

K-Number K153486

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MNI 2016-04-01

Premier

Applicant Shandong Weigao Orthopaedic Device Co., Ltd.

K-Number K160320

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