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

NHA 2021-10-20

Multi-unit Abutment, Multi-unit Angled Abutment

Applicant Megagen Implant Co., Ltd.

K-Number K203808

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JWY 2021-10-20

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

Applicant Liofilchem s.r.l.

K-Number K211672

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MZV 2021-10-20

Piccolo Potassium Test System

Applicant Abaxis, Inc.

K-Number K200865

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QKB 2021-10-20

Contour ProtegeAI

Applicant Mim Software, Inc.

K-Number K210632

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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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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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