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

ELW 2025-06-27

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

Applicant Dent4you AG

K-Number K250969

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BSP 2025-06-27

SonoPlex STIM; SonoPlex II

Applicant PAJUNK GmbH Medizintechnologie

K-Number K243682

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IZI 2025-06-27

Affirm 800

Applicant Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

K-Number K243077

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BZQ 2025-06-27

RTMsense Respiratory Monitoring System

Applicant Rtm Vital Signs, LLC

K-Number K243183

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FDS 2025-06-27

Disposable Distal Cap

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K243388

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DRF 2025-06-27

VIKING™ Fixed Curve Diagnostic Catheter

Applicant Boston Scientific Corporation

K-Number K250310

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DZL 2025-06-27

USTOMED Bone Fixation/Bone Augmentation Systems - PIN

Applicant Ustomed Instrumente Ulrich Storz GmbH & Co. KG

K-Number K243190

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DQY 2025-06-27

CPS Locator 3D Plus Delivery Catheter

Applicant CenterPoint Systems, LLC

K-Number K250828

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LHN 2025-06-27

eMotus Respiratory Motion Management System

Applicant Empnia, Inc.

K-Number K243900

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EZD 2025-06-27

Luja Coudé

Applicant Coloplast Corp.

K-Number K251116

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JOY 2025-06-27

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

Applicant Scopio Labs , Ltd.

K-Number K243144

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OMP 2025-06-27

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

Applicant Cork Medical

K-Number K243187

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