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

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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QZO 2024-01-12

Osteoboost Belt

Applicant Bone Health Technologies, Inc.

K-Number DEN230015

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HRS 2024-01-12

Quick - Radius Disposable Set

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K231684

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JDR 2024-01-12

ATOMIC Nitinol Fixation System

Applicant Rmr Ortho, LLC

K-Number K232990

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