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

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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QIH 2025-06-30

PIUR tUS inside

Applicant Piur Imaging GmbH

K-Number K250484

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DQY 2025-06-29

Primum Hydrophilic Guiding Catheter

Applicant Pendracare

K-Number K250972

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QZB 2025-06-27

Maestro System (REF100)

Applicant Moon Surgical

K-Number K250984

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FOZ 2025-06-27

BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K251654

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