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

FRO 2024-06-18

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K-Number K240552

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NXC 2024-06-18

Invisalign System

Applicant Align Technology, Inc.

K-Number K241412

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HSB 2024-06-18

Fitbone Trochanteric

Applicant Orthofix Srl

K-Number K233867

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GCJ 2024-06-18

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)

Applicant Yuwonmeditech Co., Ltd.

K-Number K240196

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MBH 2024-06-18

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

Applicant Depuy Ireland UC

K-Number K240678

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CAF 2024-06-18

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter

Applicant Thayer Medical Corporation

K-Number K233553

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CGN 2024-06-17

Elecsys Folate III

Applicant Roche Diagnostics

K-Number K233060

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OLO 2024-06-17

CROSSNAV Navigation Enabled Instruments

Applicant DePuy Synthes

K-Number K233255

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IYN 2024-06-17

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K240684

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NFT 2024-06-17

AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K241428

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MRW 2024-06-17

Ion 3D

Applicant SurGenTec, LLC

K-Number K241416

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PNO 2024-06-17

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter

Applicant Transit Scientific, LLC

K-Number K232258

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