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

DXO 2020-06-18

OptoMonitor 3

Applicant Opsens, Inc.

K-Number K193620

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MQV 2020-06-18

SIGNAFUSE Bioactive Bone Graft

Applicant Bioventus

K-Number K193513

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ODC 2020-06-18

Andorate Biopsy Valve, Andorate Biopsy Irrigator

Applicant Ga Health Company Limited

K-Number K200481

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LLZ 2020-06-17

AI-Rad Companion Brain MR

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193290

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FRO 2020-06-17

LT Antibacterial Alginate with Silver Dressing

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K-Number K192478

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LPL 2020-06-17

Miru 1day UpSide (midafilcon A)

Applicant Menicon Co, Ltd.

K-Number K193399

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HWC 2020-06-17

Medline UNITE Jones Fracture Screw System

Applicant Medline Industires, Inc.

K-Number K201319

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QAS 2020-06-17

qER

Applicant Qure.Ai Technologies

K-Number K200921

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MRN 2020-06-17

INOmax DSIR Plus

Applicant Mallinckrodt Manufacturing, LLC

K-Number K200389

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GEI 2020-06-17

ArtiSential Laparoscopic Instruments - Electrodes

Applicant Livsmed, Inc.

K-Number K200875

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FRA 2020-06-17

Aerus Medical Guardian,model F170A

Applicant Aerus Medical, LLC

K-Number K201220

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KWQ 2020-06-17

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

Applicant Spinal Elements, Inc.

K-Number K201029

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