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

OHV 2025-05-13

Ulthera System (UC-1 Control Unit PRIME Model 2.1)

Applicant Ulthera, Inc.

K-Number K250418

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OBO 2025-05-12

SPECTRALIS HRA+OCT and variants

Applicant Heidelberg Engineering GmbH

K-Number K250868

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EBF 2025-05-12

Reon

Applicant C.E.I.B.Med

K-Number K250763

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MBI 2025-05-12

Shoulder Soft Tissue Anchors

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K242477

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LLZ 2025-05-12

uWS-Angio Basic

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K243632

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QHE 2025-05-12

Archer PSI System

Applicant 3D-Side

K-Number K243509

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QPB 2025-05-12

AYON Body Contouring System (AYON SYSTEM)

Applicant Apyx Medical Corporation

K-Number K244050

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GEX 2025-05-12

Medical Diode Laser Hair Removal System (MNLT-D1)

Applicant Shandong Moonlight Electronics Tech Co., Ltd.

K-Number K250431

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OWQ 2025-05-12

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

Applicant Northeast Scientific, Inc.

K-Number K250592

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EIH 2025-05-12

ZircaGlow & ZircaGlow HT Zirconia

Applicant United Zirconia

K-Number K250393

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LHN 2025-05-12

P-Cure Proton Therapy System (PPTS)

Applicant P-Cure, Ltd.

K-Number K242418

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QEW 2025-05-12

InThrill Thrombectomy System

Applicant Inari Medical, Inc.

K-Number K250421

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