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

LFD 2025-05-19

CloSYS® Dry Mouth Sensitive Mouth Rinse

Applicant Rowpar Pharmaceuticals, Inc.

K-Number K250390

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BZD 2025-05-19

AirFit F20 Mask System; AirFit F20 NM Mask System

Applicant Resmed Pty , Ltd.

K-Number K242547

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JAK 2025-05-16

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K243617

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MQV 2025-05-16

Synthecure Synthetic Calcium Sulfate

Applicant Austin Medical Ventures, Inc.

K-Number K250141

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PHX 2025-05-16

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

Applicant Encore Medical L.P.

K-Number K251184

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FOZ 2025-05-16

Ruby Intravascular Catheter

Applicant Venocare, Inc.

K-Number K243105

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IYN 2025-05-16

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Applicant Esaote, S.p.A.

K-Number K241671

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OEB 2025-05-16

InferRead Lung CT.AI

Applicant Infervision Medical Technology Co., Ltd.

K-Number K240554

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BTA 2025-05-16

Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)

Applicant Shenzhen Desida Technology Co., Ltd.

K-Number K244033

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NHJ 2025-05-16

Clearo

Applicant Breas Medical AB

K-Number K242438

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IYE 2025-05-16

Mobius3D (4.1)

Applicant Varian Medical Systems

K-Number K250099

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DRG 2025-05-16

iBSM

Applicant Iorbit Digital Technologies Private Limited

K-Number K243837

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