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

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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NLH 2024-06-07

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K240972

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QIH 2024-06-07

Cardiac CT Function Software Application

Applicant Circle Cardiovascular Imaging

K-Number K241038

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PKL 2024-06-07

Disposable Hemostatic Clips

Applicant Ningbo Xinwell Medical Technology Co., Ltd.

K-Number K232969

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MHX 2024-06-07

Corvair

Applicant AliveCor, Inc.

K-Number K231010

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