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

MQK 2022-10-31

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

Applicant Bonraybio Co., Ltd.

K-Number K221810

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PGY 2022-10-31

CL24N

Applicant Wide Corporation

K-Number K222717

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NFJ 2022-10-31

Excelsior

Applicant Merit Cro, Inc.

K-Number K220929

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QUH 2022-10-30

Nuheara IQbuds 2 PRO Hearing Aid

Applicant Nuheara Limited

K-Number K221064

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OWN 2022-10-28

VS3-Iridium System (VS3-IR)

Applicant Visionsense, Ltd.

K-Number K223020

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NJD 2022-10-28

JOURNEY II UK and ENGAGE Cementless Partial Knee System

Applicant Smith+Nephew, Inc.

K-Number K222653

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OLO 2022-10-28

Remi Robotic Navigation System

Applicant Fusion Robotics, LLC

K-Number K223070

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IYN 2022-10-28

Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40

Applicant Supersonic Imagine

K-Number K222191

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EBF 2022-10-28

Stela Capsule System

Applicant Sdi Limited

K-Number K222583

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LNH 2022-10-28

Stage

Applicant Spintech, Inc.

K-Number K223079

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NKB 2022-10-28

Spinal Inner Fixation System

Applicant Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K-Number K222031

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CAF 2022-10-28

Vapotherm Aerosol Adapter AAA-2

Applicant Vapotherm, Inc.

K-Number K220869

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