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

EIA 2025-11-03

Midmark Dental Delivery System

Applicant Midmark Corporation

K-Number K251626

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QIH 2025-11-03

3mensio Workstation

Applicant Pie Medical Imaging BV

K-Number K250330

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IYN 2025-11-03

Sonosite MT Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K253448

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MZP 2025-11-03

cobas HCV

Applicant Roche Molecular Systems, Inc.

K-Number K252484

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HRX 2025-11-03

Kyphoplasty Balloon Dilatation Catheters

Applicant Shanghai Lange Medtech Co., Ltd.

K-Number K252458

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ITI 2025-11-03

Electric wheelchair (NSDS-01)

Applicant Hebei Dansong Medical Technology Co., Ltd.

K-Number K252671

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LLZ 2025-11-03

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant Mighty Oak Medical

K-Number K251532

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LRK 2025-11-03

NightGuard Aire Max

Applicant Nightguard Express, LLC

K-Number K252698

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PAB 2025-11-03

cobas CMV

Applicant Roche Molecular Systems, Inc.

K-Number K252481

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OLO 2025-10-31

Firebird SI Navigation System

Applicant Orthofix US, LLC

K-Number K252088

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MBH 2025-10-31

Freedom Metaphyseal Cone Implants (Metaphyseal Cones)

Applicant Maxx Orthopedics, Inc.

K-Number K252777

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GEI 2025-10-31

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

Applicant Applied Medical Resources Corporation

K-Number K252412

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