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

QQX 2023-10-13

Xpert® Xpress CoV-2 plus

Applicant Cepheid®

K-Number K230440

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MQC 2023-10-13

Serena Sleep Night Guard

Applicant Meris Investment Group

K-Number K230495

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FYA 2023-10-12

Skypro, Surgical Gown 6021

Applicant Skypro Medical Supplies Company

K-Number K230707

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GXP 2023-10-12

MONTAGE-QS Settable, Resorbable Bone Putty

Applicant Orthocon, Inc.

K-Number K231475

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JAK 2023-10-12

Scenaria View 4.2

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K231574

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MTJ 2023-10-12

Montage- XT Settable, Resorbable Hemostatic Bone Putty

Applicant Orthocon, Inc.

K-Number K232998

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GEI 2023-10-12

Monopolar Electrode Surgical Instrument

Applicant Vhmed (Nantong) Co. , Ltd.

K-Number K230650

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QTZ 2023-10-12

Artemis, Artemis TPO, Artemis MX

Applicant Eigen

K-Number K222222

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OVD 2023-10-12

Stable-L Standalone Lumbar Interbody System

Applicant Nexus Spine, LLC

K-Number K231486

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OZT 2023-10-12

ValvuloPro Valvuloplasty Balloon Catheter

Applicant Dongguan TT Medical, Inc.

K-Number K231814

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JXI 2023-10-12

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)

Applicant Axogen Corporation

K-Number K231708

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HWC 2023-10-12

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices

Applicant Paragon 28, Inc.

K-Number K231231

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