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

FGB 2024-01-17

Video Ureteroscope System

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K231135

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QFM 2024-01-17

Radify Triage

Applicant Envisionit Deepai, Ltd.

K-Number K231871

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PGT 2024-01-17

Symphion Operative Hysteroscopy System

Applicant Minerva Surgical, Inc.

K-Number K233710

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DSY 2024-01-17

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

Applicant Peca Labs, Inc.

K-Number K233783

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JXG 2024-01-17

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

Applicant Integra Lifesciences Production Corporation

K-Number K233445

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JAK 2024-01-17

Clear Guide SCENERGY

Applicant Clear Guide Medical

K-Number K234030

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LLZ 2024-01-17

FlexView Diagnostic (v1.1.20)

Applicant Radical Imaging, LLC

K-Number K233226

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NRY 2024-01-17

Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set

Applicant Cerenovus, Inc.

K-Number K233988

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KCT 2024-01-16

Washtrays

Applicant Dentsply Sirona

K-Number K231144

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GAP 2024-01-16

Non absorbable Surgical Silk Suture

Applicant Shandong Haidike Medical Product Co., Ltd.

K-Number K232355

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FMK 2024-01-16

Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K233796

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QIH 2024-01-16

Rapid (6.0)

Applicant Ischemaview, Inc.

K-Number K233512

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