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

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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QFO 2019-07-17

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K191578

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LRK 2019-07-17

Silent Nite sl

Applicant Prismatik Dentalcraft, Inc.

K-Number K183270

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PKT 2019-07-17

Powersculp laser lipolysis system

Applicant Wuhan Lotuxs Technology Co., Ltd.

K-Number K191068

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HRS 2019-07-17

ORTHOLOC™ SPS Shoulder Plating System

Applicant Tornier, Inc.

K-Number K191711

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