Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

DXC 2017-01-26

IntraClude Intra-Aortic Occlusion Device

Applicant Edwards Lifesciences, LLC

K-Number K163693

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OMP 2017-01-26

V.A.C.ULTA Negative Pressure Wound Therapy System

Applicant Kci USA, Inc. (Kinetic Concepts, Inc.)

K-Number K162790

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HSB 2017-01-26

FITBONE TAA

Applicant Wittenstein Intens GmbH

K-Number K163368

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LOX 2017-01-26

Pantera LEO

Applicant Biotronik, Inc.

K-Number K163660

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HRS 2017-01-26

dynaMX™ Compression Plate

Applicant Mx Orthopedics, Corp.

K-Number K161303

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FGE 2017-01-25

Reliant Multistage Dilatation Balloon Catheter

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K162226

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MAX 2017-01-25

Altus Spine Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K160976

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MBB 2017-01-25

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis

Applicant Biomet, Inc.

K-Number K161273

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DXC 2017-01-25

PreludeSYNC Radial Compression Device

Applicant Merit Medical Systems, Inc.

K-Number K162988

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MBI 2017-01-25

CrossFT Knotless Suture Anchor with Disposable Driver

Applicant Conmed Corporation

K-Number K163258

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NKB 2017-01-25

PASS LP Spinal System

Applicant Medicrea International SA

K-Number K162786

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GEI 2017-01-24

Barrx Anorectal RFA Wand

Applicant Covidien, LLC

K-Number K162802

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