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

LLL 2025-09-19

Alegria Flash ENA Screen

Applicant Zeus Scientific

K-Number K250408

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ELC 2025-09-19

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

Applicant Nakanishi, Inc.

K-Number K251689

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ITX 2025-09-18

ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

Applicant Olympus Medical Systems Corporation

K-Number K250883

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EKX 2025-09-18

InnerView System

Applicant Perimetrics, Inc.

K-Number K251597

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MAX 2025-09-18

Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))

Applicant Mobarn Medical Devices, LLC

K-Number K251479

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ITI 2025-09-18

Electric Wheelchair (Model P2)

Applicant Superpi Robot Co., Ltd.

K-Number K252428

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QIH 2025-09-18

Axial3D Insight

Applicant Axial Medical Printing Limited

K-Number K250369

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NFO 2025-09-18

Sunny Plus (Sunny)

Applicant ShenB Co., Ltd.

K-Number K251649

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IRP 2025-09-18

Normatec Elite Hip

Applicant NormaTec Industries, LP

K-Number K251905

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HGX 2025-09-18

Magic InBra

Applicant Medela AG

K-Number K251377

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KRH 2025-09-17

Carpentier-Edwards Physio Annuloplasty Ring (4450)

Applicant Edwards Lifesciences, LLC

K-Number K251688

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MXD 2025-09-17

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

Applicant Abbott

K-Number K251221

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