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

OAS 2019-04-24

RAYSCAN a-Expert3D

Applicant Ray Co., Ltd.

K-Number K190812

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DXN 2019-04-24

A&D Medical Blood Pressure Monitors

Applicant A&D Company, Ltd.

K-Number K173065

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NRY 2019-04-24

AXS Vecta Aspiration System

Applicant Stryker Neurovascular

K-Number K190212

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KNS 2019-04-23

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

Applicant Sumitomo Bakelite Co., Ltd.

K-Number K190621

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MQV 2019-04-23

NanoBone SBX PUTTY, NanoBone QD

Applicant Artoss GmbH

K-Number K190110

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DRF 2019-04-23

Reprocessed Supreme Diagnostic Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K182386

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LIT 2019-04-23

EverCrossTM 0.035 OTW PTA Dilatation Catheter

Applicant Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)

K-Number K190753

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FAD 2019-04-23

Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set

Applicant Cook Incorporated

K-Number K181971

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FEB 2019-04-23

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor

Applicant Advanced Sterilization Products (Asp)

K-Number K181472

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FMG 2019-04-23

Elcam Stopcocks and Manifolds

Applicant Elcam Medical Acal

K-Number K190489

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FAJ 2019-04-23

Flexible HD Cysto-Urethroscope System

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K182723

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GEH 2019-04-22

CryoLab

Applicant Cryoconcepts LP

K-Number K190407

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