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

PSN 2022-03-11

Demetra Dermatoscope BDEM-01

Applicant Barco N.V.

K-Number K213957

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JAK 2022-03-11

CardIQ Suite

Applicant GE Medical Systems SCS

K-Number K213725

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HRS 2022-03-11

Intai Anatomic Locking Plate and Screw System

Applicant Intai Technology Corporation

K-Number K201229

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MOS 2022-03-11

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch

Applicant Neocoil, LLC

K-Number K213687

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KWS 2022-03-11

TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)

Applicant Smith & Nephew, Inc.

K-Number K213827

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GXI 2022-03-11

Intracept Intraosseous Nerve Ablation System

Applicant Relievant Medsystems, Inc.

K-Number K213836

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HRS 2022-03-11

Apollo Ankle Fracture Plating System

Applicant Glw Medical, Inc.

K-Number K213005

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EBW 2022-03-11

Dental Electric Motor

Applicant Foshan Cicada Dental Instrument Co, Ltd.

K-Number K202075

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PKC 2022-03-11

Shoulder Innovations Total Shoulder System

Applicant Shoulder Innovations, Inc.

K-Number K213615

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MTJ 2022-03-11

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

Applicant Orthocon, Inc.

K-Number K220315

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OLI 2022-03-11

PHantom Trilogy

Applicant Resurgeonz, LLC

K-Number K213534

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NVK 2022-03-11

DEKA SMARTPERIO

Applicant El.En Electronic Engineering Spa

K-Number K213658

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