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

NRY 2017-04-20

Penumbra 3D Revascularization Device

Applicant Penumbra, Inc.

K-Number K162901

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EIA 2017-04-20

K3

Applicant Osstem Implant Co., Ltd.

K-Number K152830

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FPA 2017-04-20

Sterile Single-use Infusion Set

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K-Number K163160

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DXN 2017-04-20

HEM-9210T

Applicant Omron Healthcare, Inc.

K-Number K163235

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OVD 2017-04-20

Ax Stand-Alone ALIF System

Applicant Innovasis, Inc.

K-Number K162236

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LNH 2017-04-20

HyperSense

Applicant Ge Medical Systems, LLC

K-Number K162722

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GEX 2017-04-19

LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock

Applicant Patient Pocket, LLC

K-Number K170215

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HRS 2017-04-19

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System

Applicant Greens Surgicals Pvt. , Ltd.

K-Number K163383

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HQC 2017-04-19

Stellaris Elite vision enhancement system

Applicant Bausch+Lomb

K-Number K170052

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MQC 2017-04-19

Ortho System

Applicant 3Shape A/S

K-Number K161884

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JPA 2017-04-19

TEG 6s Hemostasis System

Applicant Haemonetics Corporation

K-Number K160502

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FLL 2017-04-19

VisioFocus Mini, VisioFocus Smart

Applicant Tecnimed S.R.L.

K-Number K160680

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