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

EOB 2017-08-25

ShenDa Sinuscope

Applicant Shenyang Shenda Endoscope Co., Ltd.

K-Number K161298

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MEA 2017-08-24

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

Applicant Smiths Medical Ads, Inc.

K-Number K170982

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MCW 2017-08-24

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K-Number K172386

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GEX 2017-08-24

VenaCure EVLT NeverTouch Procedure Kit

Applicant AngioDynamics, Inc.

K-Number K171921

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MNT 2017-08-24

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small

Applicant Fisher and Paykel Healthcare Limited

K-Number K170367

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HSB 2017-08-24

PRECICE UNYTE System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K172061

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HGM 2017-08-24

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring

Applicant Farus, LLC

K-Number K171865

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IYN 2017-08-24

RS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K171048

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MUJ 2017-08-24

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review

Applicant Brainlab AG

K-Number K170750

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HRS 2017-08-24

OrthoPediatrics Titanium PediPlates® System

Applicant OrthoPediatrics Corp.

K-Number K171173

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MAI 2017-08-24

Fixone Biocomposite Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K171299

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MQV 2017-08-24

MagnetOs Putty

Applicant Kuros Biosciences B.V

K-Number K171563

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