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

DSI 2019-03-26

MobileECG 2 BT

Applicant Memtec Corporation

K-Number K181658

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EBW 2019-03-26

Electric Handpiece Motor

Applicant W&H Dentalwerk Buermoos GmbH

K-Number K181858

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LLZ 2019-03-26

Synapse PACS

Applicant Fujifilm Corporation

K-Number K190232

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FPA 2019-03-26

Velano Vascular Q2 Extension Set

Applicant Velano Vascular

K-Number K182897

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HWC 2019-03-26

Arthrex TensionLoc System

Applicant Arthrex, Inc.

K-Number K183628

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NQQ 2019-03-26

OTIS Optical Coherence Tomography SYstem

Applicant Perimeter Medical Imaging, Inc.

K-Number K190404

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DYB 2019-03-26

transGlideXT Expandable Introducer

Applicant Transaortic Medical, Inc.

K-Number K181817

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IRP 2019-03-25

Ballancer Gold, 1212

Applicant Mego Afek AC , Ltd.

K-Number K190015

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LHQ 2019-03-25

InTouch Thermal Camera

Applicant Intouch Technologies, Inc., D.B.A. Intouch Health

K-Number K181716

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MEH 2019-03-25

MUTARS Proximal Femur Replacement System

Applicant Implantcast GmbH

K-Number K181778

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KNS 2019-03-25

Rezum Delivery Device, Rezum Generator

Applicant Nxthera (A Boston Scientific Company)

K-Number K190093

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PCU 2019-03-25

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

Applicant Boston Scientific Corporation

K-Number K181905

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