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

NXC 2019-12-20

DenMat Orthodontic Aligners

Applicant Denmat Holdings, LLC

K-Number K192470

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LXH 2019-12-20

SX-One MicroKnife

Applicant Sonex Health, Inc.

K-Number K192873

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EBF 2019-12-20

R&D Series Nova Compo N

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K192178

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GEX 2019-12-20

Soli-Lite LG4 Galileo

Applicant Silhouet-Tone Corporation

K-Number K192755

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CDZ 2019-12-20

ACTIVE® Free Testosterone RIA

Applicant Immunotech S.R.O.

K-Number K191350

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SBF 2019-12-20

xvision Spine system (XVS)

Applicant Augmedics, Ltd.

K-Number K190929

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MQC 2019-12-20

Ceramill A-Splint

Applicant Amann Girrbach AG

K-Number K191836

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GEI 2019-12-20

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets

Applicant Erbe Elektromedizin GmbH

K-Number K191234

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QEW 2019-12-20

Indigo Aspiration System

Applicant Penumbra, Inc.

K-Number K192833

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FRO 2019-12-20

IODOSORB

Applicant Smith & Nephew Medical, Ltd.

K-Number K190730

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MAX 2019-12-20

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K-Number K192718

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KDN 2019-12-20

Paragonix SherpaPak Pancreas Transport System

Applicant Paragonix Technologies

K-Number K191440

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