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

NKB 2020-04-30

CarboClear® II Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K200519

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DXG 2020-04-30

PulsioFlex Monitoring System with ProAQT Sensor

Applicant Pulsion Medical Systems SE

K-Number K192169

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FRG 2020-04-30

Turbett Instrument Pod

Applicant Turbett Surgical, Inc.

K-Number K200240

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KWQ 2020-04-30

Biolign® Roto-Loc Cervical Plate System

Applicant Elite Surgical Supplies (Pty), Ltd.

K-Number K200523

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KGN 2020-04-29

PELNAC Bilayer Wound Matrix

Applicant Gunze Limited

K-Number K191992

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NAY 2020-04-29

da Vinci Xi Surgical System, da Vinci X Surgical System

Applicant Intuitive Surgical

K-Number K192803

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GCJ 2020-04-29

GelPOINT Mini Advanced Access Platform

Applicant Applied Medical

K-Number K191866

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JXG 2020-04-29

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Applicant Irras USA, Inc.

K-Number K200807

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PHX 2020-04-29

Humeral Cup Stability & Humeral Cup 135/145o Stability

Applicant Fx Shoulder USA, Inc.

K-Number K193394

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PKC 2020-04-29

Exactech® Equinoxe® Stemless Humeral Components

Applicant Exactech, Inc.

K-Number K192097

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LNH 2020-04-29

Evry

Applicant Synaptive Medical, Inc.

K-Number K200327

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LZO 2020-04-29

M-Vizion Femoral Revision System Extension

Applicant Medacta International S.A.

K-Number K191816

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