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

MQC 2024-08-08

GR Resin System MSI

Applicant Pro3Dure Medical

K-Number K231775

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KPS 2024-08-08

Omni Legend

Applicant Ge Medical Systems Israel, Functional Imaging

K-Number K241665

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OSF 2024-08-08

HipXpert and HipInsight System

Applicant Surgical Planning Associates, Inc.

K-Number K233315

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GCJ 2024-08-07

Stellar Imaging System

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K241530

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NGX 2024-08-07

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K241685

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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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