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

MQB 2019-01-09

Wireless Digital Flat Panel Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K183422

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EOB 2019-01-09

PENTAX Medical EPK-3000 Video Imaging System

Applicant Pentax of America, Inc.

K-Number K182846

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KGO 2019-01-09

Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs

Applicant Smart Glove Corporation Sdn. Bhd.

K-Number K181047

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EBF 2019-01-09

Fit SA

Applicant Shofu Dental Corporation

K-Number K182869

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MBI 2019-01-09

Cortical Fixation Systems

Applicant Cousin Biotech Sas

K-Number K181086

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MBI 2019-01-08

TruShot with Y-Knot Shallow All-Suture Anchor

Applicant Conmed Corporation

K-Number K182439

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NXC 2019-01-08

Park Dental Research Aligners

Applicant Park Dental Research Corporation

K-Number K180648

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IYN 2019-01-08

HS30 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K182632

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LZG 2019-01-08

Omnipod Insulin Management System, Omnipod DASH Insulin Management System

Applicant Insulet Corporation

K-Number K182630

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OLO 2019-01-08

Choice Spine Navigation System

Applicant Choicespine, LP

K-Number K182721

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MUD 2019-01-08

INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

Applicant Covidien, LLC

K-Number K182868

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OUY 2019-01-08

BD MAX CTGCTV2, BD MAX System

Applicant Becton, Dickinson and Company

K-Number K182692

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