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

LBH 2024-06-13

ProMin Dental Desensitizing Gel

Applicant Belport Company, Inc., Gingi-Pak

K-Number K231060

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FDA 2024-06-13

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K233321

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HWC 2024-06-13

Arthrex Cannulated Screw System

Applicant Arthrex, Inc.

K-Number K240815

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GEX 2024-06-13

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

Applicant Sun Pharmaceutical Industries, Inc.

K-Number K241358

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BTT 2024-06-13

F&P Optiflow Oxygen Kit (AA451J)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K233821

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DYB 2024-06-13

Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)

Applicant ABBOTT MEDICAL

K-Number K241370

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MBF 2024-06-12

Identity Shoulder System

Applicant Zimmer, Inc.

K-Number K240876

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QJY 2024-06-12

Remunity System

Applicant Deka Research and Development

K-Number K240256

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IYO 2024-06-12

ACUSON SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K233613

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PML 2024-06-12

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

Applicant Medacta International S.A.

K-Number K241034

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OBJ 2024-06-12

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Applicant Biosense Webster, Inc.

K-Number K240050

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DTZ 2024-06-12

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

Applicant Medtronic, Inc.

K-Number K241352

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