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

PEK 2022-03-11

Minuteman G5 MIS Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K211880

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GYD 2022-03-11

Personal Kinetigraph (PKG) System Gen 2 Plus

Applicant Gkc Manufacturing Pty, Ltd.

K-Number K211887

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FMF 2022-03-11

Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

Applicant Shandong Weigao Group Medical Polymer Co., Ltd.

K-Number K212920

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HRS 2022-03-11

Pectus Support Bar System

Applicant Biomet Microfixation

K-Number K213712

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MUH 2022-03-11

Dental sensors NanoPix1, NanoPix2

Applicant Iray Technology Taicang , Ltd.

K-Number K220422

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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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