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

FGB 2023-02-02

StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring

Applicant Boston Scientific Corporation

K-Number K221515

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HFX 2023-02-02

Wee Bell

Applicant Wee Medical

K-Number K221356

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LLZ 2023-02-02

Atomica Planner

Applicant Atomica Technology, Inc.

K-Number K230012

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GXY 2023-02-02

DeltaScan Patch

Applicant Prolira B.V.

K-Number K222671

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OVE 2023-02-02

Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

Applicant 4Web Medical, Inc.

K-Number K223362

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JXG 2023-02-01

Certas Plus Programmable Valves

Applicant Integra Lifesciences Production Corporation

K-Number K223330

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GEX 2023-02-01

LED Light Therapy Device, KN-7000L

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K222751

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QFM 2023-02-01

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K230020

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QVA 2023-02-01

RefleXion Medical Radiotherapy System (RMRS)

Applicant Reflexion Medical, Inc.

K-Number DEN220014

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KLW 2023-02-01

Tinnitogram Signal Generator

Applicant Goldenear Company, Inc.

K-Number K221168

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QIH 2023-02-01

Rapid RV/LV

Applicant Ischemaview, Inc.

K-Number K223396

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PBF 2023-02-01

EmbedMed

Applicant 3D Lifeprints UK , Ltd.

K-Number K221943

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