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

OHS 2024-07-25

PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)

Applicant Dongguan Hunter Electronic Technology Co., Ltd.

K-Number K241203

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MBI 2024-07-25

Grappler Interference Screw System

Applicant Paragon 28, Inc.

K-Number K241864

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HIG 2024-07-25

Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)

Applicant Hologic, Inc.

K-Number K240886

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QNP 2024-07-25

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K241887

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NHA 2024-07-25

s-Clean ScanHealing Abutment

Applicant Dentis Co., Ltd.

K-Number K241063

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OLO 2024-07-24

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

Applicant Point Robotics MedTech, Inc.

K-Number K241130

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GCJ 2024-07-24

P-SCOPE

Applicant Oui Medical, Inc.

K-Number K241502

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EMA 2024-07-24

Insure® Universal; Insure® Universal Automix

Applicant Cosmedent, Inc.

K-Number K240714

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GEI 2024-07-24

InMode RF System

Applicant InMode , Ltd.

K-Number K240780

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GEH 2024-07-24

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

Applicant Pentax of America, Inc.

K-Number K240457

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MUI 2024-07-24

Non-Sterile Ultrasound Transmission Gels

Applicant Hony Medical Co., Ltd.

K-Number K241789

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NPM 2024-07-24

THE Graft Collagen

Applicant Purgo Biologics, Inc.

K-Number K230305

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