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

GCJ 2025-01-22

Arthrex NanoScope System

Applicant Arthrex, Inc.

K-Number K243008

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GWF 2025-01-22

Nicolet EDX

Applicant Natus Neurology Incorporated

K-Number K243982

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QIH 2025-01-22

Rapid Neuro3D

Applicant Ischemaview, Inc.

K-Number K243350

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LPH 2025-01-22

EMPHASYS Acetabular System

Applicant Depuy Ireland UC

K-Number K243977

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OMB 2025-01-22

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Applicant Persyst Development Corporation

K-Number K242446

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GEI 2025-01-22

JETT Medical II

Applicant Compex, Spol, S.R.O.

K-Number K240311

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LHI 2025-01-22

Rio Drug Reconstitution Transfer Device

Applicant Icu Medical, Inc.

K-Number K243985

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FBN 2025-01-21

Biliary Pancreaticobiliary Scope System

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K241444

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GEH 2025-01-21

Advanced Cryo Wart Remover

Applicant Medical Brands Laboratories B.V.

K-Number K242288

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OWB 2025-01-21

Ziehm Vision RFD 3D

Applicant Ziehm Imaging GmbH

K-Number K243303

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NUC 2025-01-21

Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)

Applicant Hathor Professional Skincare , Ltd.

K-Number K241443

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QHE 2025-01-21

Precision AI Surgical Planning System (PAI-SPS)

Applicant Precision AI Pty, Ltd.

K-Number K243955

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