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

MQL 2024-08-07

Ultra RapidWarm Blast

Applicant Vitrolife Sweden AB

K-Number K240605

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OLO 2024-08-07

SPINEART Navigation Instrument System

Applicant Spineart SA

K-Number K241644

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LSE 2024-08-07

ADVIA Centaur EBV-VCA IgM

Applicant Biokit, S.A.

K-Number K233606

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LLM 2024-08-07

ADVIA Centaur EBV-EBNA IgG

Applicant Biokit, S.A.

K-Number K233605

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QPB 2024-08-07

Liposaver

Applicant Lhbiomed Co., Ltd.

K-Number K212969

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FRG 2024-08-07

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)

Applicant O&M Halyard, Inc.

K-Number K240330

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ITI 2024-08-07

Electric Wheelchair (JLE-W01A-2023)

Applicant Zhejiang Jianrui Technology Company Limited

K-Number K240255

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MTD 2024-08-07

Sphere-9Dx Diagnostic Catheter (AFR-00009)

Applicant Medtronic

K-Number K233433

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DYB 2024-08-06

Abiomed 14Fr Low Profile Introducer Kit

Applicant Abiomed, Inc.

K-Number K241708

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KPR 2024-08-06

EOSedge

Applicant Eos Imaging

K-Number K233920

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LZA 2024-08-06

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K241528

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QTZ 2024-08-06

myAblation Guide (VB80A)

Applicant Siemens Healthcare GmbH

K-Number K240796

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