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

QJP 2020-05-02

RIST Radial Access Catheter

Applicant Rist Neurovascular, Inc.

K-Number K200417

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DHB 2020-05-01

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

Applicant Phadia AB

K-Number K200279

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LZA 2020-05-01

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K200453

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OLP 2020-05-01

PDT-FACE

Applicant Beijing Adss Development Co., Ltd.

K-Number K192295

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QAC 2020-05-01

OGmend Implant System

Applicant Woven Orthopedic Technologies, LLC

K-Number DEN180065

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IYN 2020-05-01

EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K201012

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LLZ 2020-05-01

Optimized Positioning System (OPS) Insight

Applicant Corin USA

K-Number K192656

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FET 2020-05-01

FUJIFILM EP-6000 Video Processor

Applicant Fujifilm Corporation

K-Number K192286

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FMF 2020-05-01

O-Genesis Graft Delivery System

Applicant Orthofix, Inc.

K-Number K200606

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MQB 2020-05-01

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

Applicant Iray Technology Taicang , Ltd.

K-Number K201004

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IYE 2020-05-01

Image Guidance System for Radiotherapy

Applicant Jiangsu Rayer Medical Technology Co., Ltd.

K-Number K192405

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MQF 2020-05-01

Kitazato ET Catheters

Applicant Kitazato Corporation

K-Number K192540

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