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

QBC 2025-07-01

Felix NeuroAI System

Applicant Fasikl Incorporated

K-Number K250096

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QFG 2025-07-01

MiniMed 780G insulin pump

Applicant Medtronic Minimed, Inc.

K-Number K251032

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HSX 2025-07-01

Arthrex iBalance Partial Knee System

Applicant Arthrex, Inc.

K-Number K251453

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BSP 2025-07-01

SonoMSK

Applicant PAJUNK GmbH Medizintechnologie

K-Number K243690

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PAB 2025-07-01

Alinity m CMV

Applicant Abbott Molecular, Inc.

K-Number K243485

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OHT 2025-06-30

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

Applicant Shenzhen Chuangtong Yigou Technology Co., Ltd.

K-Number K251000

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QIH 2025-06-30

EchoConfidence (USA)

Applicant Mycardium AI Limited

K-Number K250670

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OZW 2025-06-30

Otsuka Digital Feedback Device

Applicant Otsuka America Pharmaceutical, Inc.

K-Number K251088

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CAF 2025-06-30

HeroTracker Sense

Applicant Voluntis

K-Number K250022

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MAX 2025-06-30

aprevo® posterior/transforaminal lumbar interbody fusion device

Applicant Carlsmed, Inc.

K-Number K250987

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JWY 2025-06-30

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL

Applicant Thermo Fisher Scientific

K-Number K250990

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QIH 2025-06-30

Synapse PACS (7.5)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K243647

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