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

QTZ 2025-09-08

BioTraceIO Vision (V1.7)

Applicant Techsomed Medical Technologies

K-Number K251931

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QJP 2025-09-08

DUO Microcatheter

Applicant Rev Neuro, LLC

K-Number K250960

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NAY 2025-09-08

da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251227

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QAS 2025-09-08

qER-CTA (v1.0)

Applicant Qure.Ai Technologies

K-Number K251610

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HGX 2025-09-08

Wearable Breast Pump (Model S33)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K251754

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PKL 2025-09-08

Dual Action Tissue Closure Device

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K250229

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SFD 2025-09-08

Coaptium Connect with Tissium Light

Applicant Tissium SA

K-Number K251957

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HGX 2025-09-08

Momcozy Wearable Breast Pump (BP223)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K251394

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HRS 2025-09-08

MAXXOS P.A.C.E. Foot & Ankle Plating System

Applicant Maxxos Medical GmbH

K-Number K251892

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JAK 2025-09-08

OmniTom Elite with PCD

Applicant Neurologica Corporation

K-Number K250928

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JWY 2025-09-05

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

Applicant Thermo Fisher Scientific

K-Number K250575

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FED 2025-09-05

Ureteral Access Sheath

Applicant Zhejiang YiGao Medical Technology Co., Ltd.

K-Number K250132

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