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

DLZ 2021-08-13

VITROS Chemistry Products PHBR Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K210858

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MXC 2021-08-13

Jot Dx Insertable Cardiac Monitor

Applicant Abbott (St. Jude Medical)

K-Number K212206

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GWF 2021-08-13

MEGA-TMS

Applicant Soterix Medical, Inc.

K-Number K192823

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HRS 2021-08-13

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K-Number K203817

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KIF 2021-08-13

White Endoseal MTA

Applicant Maruchi

K-Number K212229

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KNW 2021-08-12

Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K210946

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QAS 2021-08-12

InferRead CT Stroke.AI

Applicant Infervision Medical Technology Co., Ltd.

K-Number K211179

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OLO 2021-08-12

VERTICALE Navigation Instruments

Applicant Silony Medical GmbH

K-Number K212007

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KDI 2021-08-12

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Applicant Quanta Dialysis Technologies, Ltd.

K-Number K210661

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DJG 2021-08-12

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K-Number K201630

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LLZ 2021-08-12

eVolve PACS

Applicant Evolve Pacs, Inc.

K-Number K211863

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OWB 2021-08-12

Excelsius3D

Applicant Globus Medical, Inc.

K-Number K210912

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