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

DZE 2025-05-14

CeraRoot TL Implant System (TL)

Applicant Ceraroot SL

K-Number K242072

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IYN 2025-05-13

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5

Applicant Canon Medical Systems Corporation

K-Number K242808

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NKG 2025-05-13

Freedom Posterior Cervical Screws

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K242674

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PTI 2025-05-13

Promisemed Safety Huber Needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K251138

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KCT 2025-05-13

Aesculap Aicon® Series Container System

Applicant Aesculap, Inc.

K-Number K242762

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NAY 2025-05-13

SP Endoscope, 0° (430600)

Applicant Intuitive Surgical, Inc.

K-Number K250786

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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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