Zio AT device

FDA registration

IRHYTHM TECHNOLOGIES, INC.·4 products·🇺🇸 United States

Zio AT device

FDA registration

iRhythm Technologies, Inc.·4 products·🇺🇸 United States

Zio AT® device (A100A1001)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Outpatient Cardiac Telemetry

FDA classification

FDA Class 2 ·Outpatient Cardiac Telemetry

MaXcess

FDA UDI

Nuvasive, Inc.·00887517196187·MaXcess 4 Retractor, Wide Anterior Long

NeuroStar System Software

FDA registration

Neuronetics Inc.·2 products·🇺🇸 United States

SafetyNET Needle (21275-000)

FDA registration

NextPhase Medical Devices Mexico LLC·1 product·🇲🇽 Mexico

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CGuard Prime Carotid Stent System

Sleep Apnea Notification Feature

FDA registration

APPLE INC.·1 product·🇺🇸 United States

SAFETYNET GUIDEWIRE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMIPLIVUE HSV 1&2 ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CGuard Prime Carotid Stent System

FDA registration

INSPIREMD, LTD.·1 product·🇮🇱 Israel

CGuard Prime Carotid Stent System

FDA registration

INSPIREMD, INC.·1 product·🇺🇸 United States

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification

FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

Stent, Carotid

FDA classification

FDA Class 3 ·Stent, Carotid

Introducer, Catheter

FDA classification

FDA Class 2 ·Introducer, Catheter