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

CJE 2019-08-30

Yumizen C1200 ALP, Yumizen C1200 Albumin

Applicant HORIBA ABX SAS

K-Number K191245

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FED 2019-08-30

Pathfinder Endoscope Overtube

Applicant Neptune Medical, Inc.

K-Number K191415

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OAS 2019-08-30

T1-CS, T1-C

Applicant Osstem Implant Co., Ltd.

K-Number K183475

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GWG 2019-08-30

Artemis Eye System

Applicant Penumbra, Inc.

K-Number K190719

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LZC 2019-08-29

Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink

Applicant Gmp Medicare Sdn Bhd (F25)

K-Number K182382

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IYN 2019-08-29

Clarius Ultrasound Scanner

Applicant Clarius Mobile Health Corp.

K-Number K192107

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DQK 2019-08-29

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

Applicant Edwards Lifesciences, LLC

K-Number K190205

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HET 2019-08-29

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

Applicant Olympus Winter & Ibe GmbH

K-Number K190744

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FYD 2019-08-29

EvaQMax Smoke Evacuation System

Applicant Bio Protech, Inc.

K-Number K192035

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KCT 2019-08-29

Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate

Applicant Nobel Biocare AB

K-Number K191475

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DZE 2019-08-29

SGS Dental Implants System

Applicant Sgs International, Ltd.

K-Number K182219

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LLZ 2019-08-29

D2P

Applicant 3D Systems, Inc.

K-Number K183489

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