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

OZN 2021-10-20

cobas Cdiff nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K212427

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QQU 2021-10-20

Luminopia One

Applicant Luminopia, Inc.

K-Number DEN210005

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DZE 2021-10-20

S.I.N. Dental Implant System

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K211921

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DQK 2021-10-20

AVVIGO Guidance System II

Applicant Boston Scientific Corporation

K-Number K212490

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JTY 2021-10-20

InTray GC

Applicant Biomed Diagnostics Incorporated

K-Number K210511

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LLZ 2021-10-20

iRAD

Applicant Claritas Healthtech Pte, Ltd.

K-Number K212470

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OCX 2021-10-20

Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series

Applicant Chongqing Jinshan Science & Technology Co., Ltd.

K-Number K210618

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LQY 2021-10-20

EQ-PEX

Applicant Meta Systems Co., Ltd.

K-Number K210789

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GEX 2021-10-19

PICOHI

Applicant Hironic Co., Ltd.

K-Number K201773

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FIP 2021-10-19

U9000 Plus Ultrafilter

Applicant Baxter Healthcare Corporation

K-Number K211035

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LZA 2021-10-19

Nitrile Examination Gloves

Applicant Niujian Technology Co., Ltd.

K-Number K210706

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DXT 2021-10-19

Sterile High-pressure Angiographic Syringes for Single-use

Applicant Shenzhen Boon Medical Supply Co., Ltd.

K-Number K211564

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