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

MBI 2024-01-17

Footprint Mini PK, 3.5mm Suture Anchor

Applicant Smith & Nephew

K-Number K233730

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LDJ 2024-01-17

Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

Applicant Co-Innovation Biotech Co., Ltd.

K-Number K232732

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KNW 2024-01-17

M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle

Applicant Canyon Medical, Inc.

K-Number K233031

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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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