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

DZE 2019-11-09

Neodent Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K190958

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LZC 2019-11-08

Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves

Applicant O&M Halyard, Inc.

K-Number K191230

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NGX 2019-11-08

HIVOX Spopad EMS SP-911, SP-921

Applicant Hivox Biotek, Inc.

K-Number K192264

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LZA 2019-11-08

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K192232

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NBW 2019-11-08

CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K-Number K191286

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EMA 2019-11-08

Visalys CemCore, Visalys Cem Core Try In Paste

Applicant Kettenbach GmbH & Co. KG

K-Number K191527

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PEA 2019-11-08

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

Applicant Pentax of America, Inc.

K-Number K191282

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OHT 2019-11-08

IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130

Applicant Shenzhen Bosidin Technology Co., Ltd.

K-Number K192432

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NDN 2019-11-08

VK100 Percutaneous Vertebral Augmentation System

Applicant Bonwrx, Ltd.

K-Number K192403

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HRS 2019-11-08

APTUS Wrist Arthrodesis Plates

Applicant Medartis AG

K-Number K192297

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LLZ 2019-11-08

QuantX Breast MRI Biopsy Guidance Plugin

Applicant Qlarity Imaging

K-Number K191959

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KWQ 2019-11-08

Oryx Cervical Plate System

Applicant Innovasis, Inc.

K-Number K192049

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