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 2016-10-27

Libra Pedicle Screw System

Applicant Spinal Balance, Inc.

K-Number K162750

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DQO 2016-10-27

Torcon NB Advantage Catheters

Applicant Cook Incorporated

K-Number K161822

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DXX 2016-10-27

CorPath GRX System

Applicant Corindus, Inc.

K-Number K160121

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BZR 2016-10-27

MaxBlend 2, MaxBlend Lite

Applicant Maxtec, LLC

K-Number K161718

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DZE 2016-10-27

ETIII SA Fixture System (O3.2mm)

Applicant Hiossen, Inc.

K-Number K153332

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GEX 2016-10-27

EdgeOne CO2 Laser

Applicant Jeisys Medical, Inc.

K-Number K162169

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BSP 2016-10-27

SPROTTE SPECIAL NRFit

Applicant PAJUNK GmbH Medizintechnologie

K-Number K160296

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KNW 2016-10-27

SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles

Applicant M.D.L. S.R.L.

K-Number K160316

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JXG 2016-10-27

Smart External Drain (SED) System

Applicant Aqueduct Critical Care, Inc.

K-Number K161605

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HEW 2016-10-27

ColpoWave Colpotomizer and CerviGrip Uterine Manipulator

Applicant Surgitools Pty , Ltd.

K-Number K161065

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MBH 2016-10-27

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

Applicant Total Joint Orthopedics, Inc.

K-Number K162256

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OBJ 2016-10-26

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

Applicant Volcano Corporation

K-Number K160583

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