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

NUH 2018-03-07

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

Applicant Bayer Healthcare, LLC

K-Number K171802

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PND 2018-03-07

primeMidline Catheters

Applicant Pfm Medical, Inc.

K-Number K173114

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KOD 2018-03-07

Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter

Applicant Cook Incorporated

K-Number K171810

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LNH 2018-03-06

Ingenia Elition S and Ingenia Elition X R5.4

Applicant Philips Medical Systems Nederland B.V.

K-Number K173356

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NKB 2018-03-06

IRENE Thoracolumbar Fixation System

Applicant Tianjin Zhengtian Medical Instrument Co., Ltd.

K-Number K172267

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IPF 2018-03-06

Digitimer DS7AP Constant Current Stimulator

Applicant Digitimer , Ltd.

K-Number K172381

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OWQ 2018-03-06

Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

Applicant Innovative Health, LLC

K-Number K173262

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KPO 2018-03-06

Citric Complete Dry Citric Acid (45X)

Applicant Dimesol USA, LLC

K-Number K171750

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LOD 2018-03-06

OrthoSteady G Bone Cement

Applicant G21, S.R.L.

K-Number K173494

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FDX 2018-03-05

Cytology Brush

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

K-Number K172663

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NUJ 2018-03-05

Reprocessed ArthoCare Ablation Wand

Applicant Renovo, Inc.

K-Number K173741

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ODP 2018-03-05

Valeo® C+CSC with Lumen Interbody Fusion Device

Applicant Amedica Corp.

K-Number K173453

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