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

NGZ 2021-12-15

Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL

Applicant Thermo Fisher Scientific

K-Number K211539

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LIT 2021-12-15

Chocolate PTA Balloon Catheter

Applicant Medtronic, Inc.

K-Number K213631

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LLZ 2021-12-15

BIT-Motion

Applicant Dde Mri Solutions, Ltd.

K-Number K211039

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FXX 2021-12-15

Surgical Face Mask (Non-sterile)

Applicant Hubei Kimsoul Industrial Co., Ltd.

K-Number K212398

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KGN 2021-12-15

Cellusheet, Cellufil

Applicant Human Biosciences, Inc.

K-Number K213092

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OUR 2021-12-15

SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K-Number K212903

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KRD 2021-12-15

Merit Siege Vascular Plug

Applicant Merit Medical System, Inc.

K-Number K212817

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FYA 2021-12-15

Surgical Gown, Reinforced Surgical Gown

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K-Number K212861

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PNO 2021-12-15

Serranator PTA Serration Balloon Catheter

Applicant Cagent Vascular, LLC

K-Number K213728

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OMP 2021-12-15

Innomed NPWT Silicone Foam Dressing

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K-Number K202823

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PEK 2021-12-15

Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K212781

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KWQ 2021-12-15

Insignia™ Anterior Cervical Plate System

Applicant Alphatec Spine, Inc.

K-Number K213443

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