MODIFICATION TO V-CATH POLY PICC

FDA 510(k)

FDA Class 2 ·General Hospital

SELDINGER SAFETY NEEDLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HDC CHEMO-PORT (VASCULAR)

FDA 510(k)

FDA Class 2 ·General Hospital

ENTERAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1

FDA 510(k)

FDA Class 2 ·General Hospital

CHEMO-PORT NON-CORING NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROTRAC

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EPICATH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER

FDA 510(k)

FDA Class 2 ·General Hospital

V-CATH POLY PICC

FDA 510(k)

FDA Class 2 ·General Hospital

CHEMO-PORT

FDA 510(k)

FDA Class 2 ·General Hospital

Samphire Neuroscience Ltd

Manufacturer

1 Basic UDI-DI·1 Device·1 Importer

BONE SOURCE HAC RAPID SETTING CEMENT

FDA 510(k)

FDA Class 2 ·Neurology

BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT

FDA 510(k)

FDA Class 2 ·Neurology

HACS-A20-1

Device

EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·On the market

HACS-A15-3

Device

EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·On the market

HACS-A15-2

Device

EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·On the market

HACS-A15-1

Device

EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·On the market

HACS-A25-5

Device

EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·On the market