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

PNL 2018-09-19

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K180894

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MQP 2018-09-19

FORTIFY Corpectomy Spacers

Applicant Globus Medical, Inc.

K-Number K173982

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LPL 2018-09-19

Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens

Applicant Visco Vision, Inc.

K-Number K181349

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OHT 2018-09-19

Beurer IPL 8500 device/ IPL VelvetSkin Pro

Applicant Home Well Trading, Ltd.

K-Number K181734

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OLO 2018-09-19

Ortoma Treatment Solution - OTS

Applicant Ortoma AB

K-Number K181449

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DZE 2018-09-19

CSM Submerged3-L Implant System

Applicant Csm Implant

K-Number K173141

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GCJ 2018-09-19

Scope Antifogging System

Applicant Xodus Medical, Inc.

K-Number K182080

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ODP 2018-09-19

TirboLOX-C Cervical IBFD

Applicant Captiva Spine, Inc.

K-Number K181229

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QSY 2018-09-19

IHM Technology Bandage

Applicant Protege Biomedical

K-Number K180893

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NBW 2018-09-19

Oh'Care Lite Smart Blood Glucose Monitoring System

Applicant Osang Healthcare Co. , Ltd.

K-Number K182286

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GZB 2018-09-19

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

Applicant Stimwave Technologies Incorporated

K-Number K180981

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HRS 2018-09-18

Tandry Locking Plate System

Applicant Microware Precision Co., Ltd.

K-Number K171904

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