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

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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PZX 2022-10-28

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

Applicant Syntheon

K-Number K220305

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GXN 2022-10-28

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Applicant Kontour(Xi’An) Medical Technology Co., Ltd.

K-Number K214109

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FYA 2022-10-28

Disposable Surgical Gown Rk-3011C

Applicant Xiantao Rhycom Non-Woven Products Co., Ltd.

K-Number K211060

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