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

MJN 2022-09-19

LANDMARK REBOA Catheter

Applicant Zien Medical Technologies, Inc.

K-Number K214060

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EBZ 2022-09-16

LEDEX

Applicant Dentmate Technology Co. , Ltd.

K-Number K221194

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MOK 2022-09-16

GelPOINT V-Path Vaginal Access System

Applicant Applied Medical Resources Corporation

K-Number K220969

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NHA 2022-09-16

Esthetic Abutments Nobel Biocare N1

Applicant Nobel Biocare Services AG

K-Number K220339

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FXX 2022-09-16

AllureTM Surgical Mask

Applicant Allure Gift Wraps Private Limited

K-Number K212926

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KWQ 2022-09-16

CYGNUS™ MoRe Anterior Cervical Plate System

Applicant MiRus, LLC

K-Number K220441

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CFR 2022-09-16

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

Applicant Roche Diagnostics

K-Number K220134

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GZL 2022-09-16

Neuro Omega System, NeuroSmart System

Applicant Alpha Omega Engineering , Ltd.

K-Number K220553

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ITI 2022-09-16

Electric Wheelchair, Model: 9000N

Applicant Silver Fox Corporation Limited

K-Number K221799

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HAW 2022-09-16

ClearPoint System

Applicant ClearPoint Neuro, Inc.

K-Number K222519

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QOG 2022-09-16

Tempo Smart Button

Applicant Eli Lilly and Company

K-Number K212217

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NKB 2022-09-16

True Tulip, True M.I.S.

Applicant Innovative Surgical Designs, Inc.

K-Number K220297

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