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

EIA 2019-07-18

Qraypen

Applicant AIOBIO Co., Ltd.

K-Number K183121

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NGX 2019-07-18

BionicGym Powered Muscle Stimulator

Applicant Medical Currents, Ltd.

K-Number K182794

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CBK 2019-07-18

Trilogy Evo

Applicant Respironics, Inc.

K-Number K181166

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NKG 2019-07-18

MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System

Applicant Medos International SARL

K-Number K190895

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DZE 2019-07-18

Ziacom Dental Implant Systems

Applicant Ziacom Medical, S.L.

K-Number K182908

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FDI 2019-07-18

AcuSnare Polypectomy Snare - Duckbill

Applicant Wilson-Cook Medical, Inc.

K-Number K191048

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NFJ 2019-07-18

Huvitz Imaging System

Applicant Huvitz Co., Ltd.

K-Number K191615

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LZO 2019-07-18

Latitud Hip Replacement System

Applicant Meril Healthcare Pvt. , Ltd.

K-Number K183532

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FMF 2019-07-18

Immucise

Applicant Terumo Corporation

K-Number K190427

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FRO 2019-07-18

Silverlon Wound Contact, Burn Contact Dressings

Applicant Argentum Medical, LLC

K-Number K190343

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CBK 2019-07-18

Trilogy Evo Universal

Applicant Respironics, Inc.

K-Number K181170

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JWH 2019-07-18

SPAR-K Instruments (for use with Gemini SL Total Knee System)

Applicant Waldemar Link GmbH & Co. KG

K-Number K191755

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