Sentry IVC Filter

FDA 510(k)

FDA Class 2 ·Cardiovascular

COLLACARE DENTAL

FDA 510(k)

FDA Unclassified ·Unknown

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

FDA 510(k)

FDA Unclassified ·Unknown

AERONEB PROFESSIONAL NEBULIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

INNOVO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMPHASYS Femoral Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE Cemented Tibial Base, Fixed Bearing

FDA 510(k)

FDA Class 2 ·Orthopedic

True Form Reshapable Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

014 Hydrophilic Coated PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Boss Crossing Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DePuy Actis DuoFix Hip Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

FDA 510(k)

FDA Class 2 ·Physical Medicine

PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

BionicGym Powered Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

HARPS Europe GmbH

Importer

🇦🇹 Austria·2 Manufacturers

spECTrum EEG/ECG Five-Lead Set-IEC (replacement)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SigmaStim Domestic LLC·1 device

spECTrum Safety Monitor Cable IEC EEG/ECG (replacement)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·SigmaStim Domestic LLC·1 device

SURGITRON 4.0 DUAL RF/90 IEC 220-240V

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Cynosure LLC·1 device

NEO HEALTHIES LIMITED

Authorized representative

🇮🇪 Ireland·4 Manufacturers·9 Devices