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

INI 2025-11-21

Powered Mobility Scooter (PMS105, GUT177, GCAT047)

Applicant Intradin (Shanghai) Machinery Co., Ltd.

K-Number K252590

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LBH 2025-11-21

FluoroDose Varnish

Applicant Centrix, Inc.

K-Number K250714

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OMP 2025-11-21

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory

Applicant Deroyal Industries, Inc.

K-Number K250586

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POS 2025-11-21

Nelli (Version 7.11)

Applicant Neuro Event Labs OY

K-Number K251506

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NHA 2025-11-21

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants

Applicant Dentsply Sirona

K-Number K251205

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ODP 2025-11-21

BEE HA

Applicant NGMedical GmbH

K-Number K250560

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KTT 2025-11-20

The Response Ortho Smart Fixator - Hexapod System

Applicant Response Ortho Solutions, LLC

K-Number K252625

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GEX 2025-11-20

CuRAS hybrid

Applicant Classys, Inc.

K-Number K253123

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GEX 2025-11-20

Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)

Applicant Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

K-Number K253007

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LLZ 2025-11-20

syngo.MR Applications (VB80)

Applicant Siemens Healthineers AG

K-Number K253495

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EBI 2025-11-20

UltraPrint-Dental Denture UV

Applicant Guangzhou Heygears IMC., Inc.

K-Number K253324

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GCJ 2025-11-20

Nuvis® Wireless HD Camera System (Nuvis-2K)

Applicant Integrated Endoscopy, Inc.

K-Number K242606

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