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

HKI 2020-06-01

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

Applicant Vasoptic Medical, Inc.

K-Number K193319

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OBR 2020-06-01

SleepRight ProRx Custom Dental Guard

Applicant Splintek, Inc.

K-Number K193577

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QEY 2020-06-01

UNI*FUSE Infusion System with Cooper Wire

Applicant AngioDynamics, Inc.

K-Number K192864

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KGO 2020-06-01

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

Applicant Hartalega Sdn Bhd

K-Number K200897

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DRG 2020-06-01

Vitls Platform

Applicant Vitls, Inc.

K-Number K191620

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GXY 2020-06-01

BRAINSTREAM Disposable Deep Cup EEG Electrodes

Applicant Conmed Corporation

K-Number K200540

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QIH 2020-06-01

uWS-MR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K192601

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MQP 2020-05-29

KONG-TL VBR System, KONG-C VBR System

Applicant Icotec AG

K-Number K200235

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MRG 2020-05-29

ADVIA Centaur Vitamin D Total (VitD)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K200509

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DQK 2020-05-29

iLab Polaris Multi-Modality Guidance System

Applicant Boston Scientific

K-Number K201178

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HAW 2020-05-29

ROSA ONE Brain application

Applicant Medtech S.A

K-Number K200511

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OWB 2020-05-29

CFP-3131, CFP-2222

Applicant Mx Imaging, Inc.

K-Number K201172

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