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

QEW 2024-06-10

Indigo® Lightning Flash Aspiration System Select + Catheter

Applicant Penumbra, Inc.

K-Number K241399

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JAK 2024-06-10

OmniTom Elite

Applicant Neurologica Corporation

K-Number K233767

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IYN 2024-06-10

Venue Fit

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K234106

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IYN 2024-06-10

Venue

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K240111

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GEH 2024-06-10

Histofreezer V

Applicant Cryoconcepts LP

K-Number K240106

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NUC 2024-06-07

Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant

Applicant Select Labs, LLC

K-Number K234099

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FAJ 2024-06-07

Uro-G HD Flexible Cystoscope

Applicant Uroviu Corporation

K-Number K232837

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FRG 2024-06-07

Steriking® Pouch for Robotic Instruments

Applicant Wipak OY

K-Number K232625

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NGZ 2024-06-07

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

Applicant bioMerieux, Inc.

K-Number K232963

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NHA 2024-06-07

IPD Dental Implant Abutments

Applicant Implant Protesis Dental 2004, S.L.

K-Number K240570

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DPS 2024-06-07

Electrocardiograph, model: ECG301

Applicant Shenzhen LE Medical Technology Co., Ltd.

K-Number K232816

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DXN 2024-06-07

Blood Pressure Monitor (BBZ32-AA01)

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K240832

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