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

MQL 2017-10-13

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

Applicant Origio A/S

K-Number K172197

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FGE 2017-10-13

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter

Applicant Wilson-Cook Medical, Inc.

K-Number K171548

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LZA 2017-10-12

Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs

Applicant Blue Sail Medical Co.,Ltd

K-Number K171782

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KGO 2017-10-12

Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

Applicant Top Glove Sdn. Bhd.

K-Number K171279

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MQB 2017-10-12

Aquarius 8600 1417TG and Aquarius 8600 1717TG

Applicant Imaging Dynamics Company , Ltd.

K-Number K171169

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LHI 2017-10-12

Vial Adapter 15mm

Applicant Medimop Medical Project , Ltd.

K-Number K171796

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MQB 2017-10-12

SKR 3000

Applicant Konica Minolta, Inc.

K-Number K172793

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MNI 2017-10-12

Mikron Spinal Fixation System

Applicant Mikron Makina Sanayi Ticaret Co. , Ltd.

K-Number K171497

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IYN 2017-10-12

SONON Ultrasound Imaging System, Model: 300L

Applicant Healcerion Co., Ltd.

K-Number K170085

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HIS 2017-10-12

JUD custom fit condom

Applicant Global Mailer Partners, LLC

K-Number K172414

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LZA 2017-10-12

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)

Applicant Hartalega Sdn Bhd

K-Number K171874

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LCP 2017-10-12

Lucica Glycated Albumin-L

Applicant Asahi Kasei Pharma Corporation

K-Number K170147

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