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 2016-07-11

MLX - Medial Lateral Expandable Lumbar Interbody System

Applicant Nu Vasive, Incorporated

K-Number K153105

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NAY 2016-07-11

da Vinci Xi Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K161271

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MAX 2016-07-11

PROW FUSION-V

Applicant Nlt Spine, Ltd.

K-Number K153786

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HRX 2016-07-11

Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula

Applicant Prosurg, Inc.

K-Number K152511

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NUC 2016-07-11

Pulse Aloe-ahh

Applicant Toaster Labs, Inc.

K-Number K152671

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NUC 2016-07-11

Pulse H20h!

Applicant Toaster Labs, Inc.

K-Number K152628

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NKG 2016-07-11

PASS OCT Spinal System

Applicant Medicrea International SA

K-Number K161149

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FMI 2016-07-11

JSM Insulin Pen Needle

Applicant Jeesung Medical Co., Ltd.

K-Number K152166

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GXI 2016-07-09

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

Applicant Relievant Medsystems

K-Number K153272

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OLO 2016-07-08

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments

Applicant Aesculap Implant Systems, LLC

K-Number K153700

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MAX 2016-07-08

AccuLIF TL and PL Cage

Applicant Stryker Corporation

K-Number K160715

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LZO 2016-07-08

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System

Applicant Zimmer GmbH

K-Number K161192

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