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

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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HSN 2023-10-12

Exactech® Vantage® Total Ankle System

Applicant Exactech, Inc.

K-Number K230717

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DXF 2023-10-12

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable

Applicant Cross Vascular, Inc.

K-Number K232852

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MQC 2023-10-12

FREEPRINT® splintmaster

Applicant Detax GmbH

K-Number K232448

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OLO 2023-10-12

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K232802

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