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

GWG 2023-10-27

Aurora Surgiscope System

Applicant Rebound Therapeutics Corporation

K-Number K232618

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DRF 2023-10-27

Polaris X Unidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K-Number K233207

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JGS 2023-10-27

i-STAT CG8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K230275

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LFY 2023-10-27

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

Applicant DiaSorin, Inc.

K-Number K231214

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GAG 2023-10-27

GIA Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K231934

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MOL 2023-10-27

45 Micron Polyisoprene Condom

Applicant Suretex Limited

K-Number K231908

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LNH 2023-10-27

Digital Expert Access with Remote Scanning

Applicant GE Healthcare

K-Number K232346

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JAK 2023-10-27

MeVis Liver Suite

Applicant MeVis Medical Solutions AG

K-Number K232045

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IRP 2023-10-27

Cold/Hot Compression

Applicant Jkh Health Co., Ltd.

K-Number K223541

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MEG 2023-10-27

Shina Syringe; Shina Safety Syringe

Applicant Shina Med Corporation

K-Number K231165

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OLP 2023-10-27

PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

Applicant Dongguan Hunter Electronic Technology Co., Ltd.

K-Number K230490

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QJQ 2023-10-27

Modius Sleep

Applicant Neurovalens , Ltd.

K-Number K230826

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