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

MHX 2024-08-01

Infinity CentralStation Wide

Applicant Draeger Medical Systems, Inc.

K-Number K240312

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HIR 2024-08-01

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

Applicant Pelvital USA, Inc.

K-Number K240805

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FGB 2024-08-01

KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

Applicant Karl Storz SE & CO. KG

K-Number K241945

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HSB 2024-08-01

DePuy Synthes Retrograde Femoral Nail Advanced System

Applicant DePuy Synthes

K-Number K233696

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FDT 2024-08-01

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

Applicant Pentax of America, Inc.

K-Number K233942

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HRS 2024-08-01

Freefix Forearm Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K242055

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EBZ 2024-08-01

LOOP™ LED Curing Light System (CLK01)

Applicant Garrison Dental Solutions, LLC

K-Number K241238

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DYB 2024-08-01

TLAB® Transvenous Liver Biopsy System (TF-18C)

Applicant Argon Medical Devices, Inc.

K-Number K241145

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NXC 2024-08-01

Clear Moves Aligner

Applicant Clear Moves Aligners

K-Number K241137

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QDQ 2024-08-01

MammoScreen® (3)

Applicant Therapixel

K-Number K240301

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KCT 2024-07-31

SteriTite rigid reusable sterilization container with MediTray Products

Applicant Case Medical

K-Number K240898

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DZE 2024-07-31

LW Narrow Implant System

Applicant Ossvis Co., Ltd.

K-Number K233808

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