ASEPT PLEURAL DRAINAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASEPT® Glide Peritoneal Drainage System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRIPLE LUMEN PFM PICC

FDA 510(k)

FDA Class 2 ·General Hospital

PICC (CT RATED AND NON-RATED)

FDA 510(k)

FDA Class 2 ·General Hospital

ASEPT PERITONEAL DRAINAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Asept Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

primeMidline Catheters

FDA 510(k)

FDA Class 2 ·General Hospital

SAFETY BIOPSY NEEDLE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO EZ HUBER SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NuCath Wedge Pressure Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·PMA NIT-OCCLUD PDA

HICO-Hose extension SP

Device

EU MDR · Eu Md Class 1 ·pfm medical hico GmbH·On the market·1 country

HICO-Polyurethane-Waterpad SP

Device

EU MDR · Eu Md Class 1 ·pfm medical hico GmbH·On the market·1 country

HICO-Polyurethane-Waterpad

Device

EU MDR · Eu Md Class 1 ·pfm medical hico GmbH·On the market·1 country

HICO-Polyurethane-Waterpad

Device

EU MDR · Eu Md Class 1 ·pfm medical hico GmbH·On the market·1 country

HICO-Polyurethane-Waterpad

Device

EU MDR · Eu Md Class 1 ·pfm medical hico GmbH·On the market·1 country