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

GAP 2024-01-16

Non absorbable Surgical Silk Suture

Applicant Shandong Haidike Medical Product Co., Ltd.

K-Number K232355

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FMK 2024-01-16

Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K233796

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QIH 2024-01-16

Rapid (6.0)

Applicant Ischemaview, Inc.

K-Number K233512

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LZA 2024-01-16

Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

Applicant Nephron Nitrile, LLC

K-Number K233970

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LRK 2024-01-16

Aniti-Snore Mouthguard+

Applicant Oscimed SA

K-Number K231138

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OTJ 2024-01-16

Uni-port

Applicant Dalim Medical Corp.

K-Number K232062

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IYE 2024-01-16

Delta4 Insight

Applicant Scandidos AB

K-Number K223234

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QGL 2024-01-16

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

Applicant Neurosigma, Inc.

K-Number K233293

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ESW 2024-01-16

Hilzo Esophageal Stents

Applicant Thoracent, Inc.

K-Number K223266

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JEY 2024-01-13

Stryker Facial iD System

Applicant Stryker Craniomaxillofacial

K-Number K232350

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QNL 2024-01-13

CLEWICU System

Applicant Clew Medical , Ltd.

K-Number K233216

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KPS 2024-01-12

Biograph VK10

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233677

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