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

MICROTARGETING GUIDELINE 4000

FDA 510(k)

FDA Class 2 ·Neurology

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

MICRO TARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING XL STAR DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

VFS1 Bipolar Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Samphire Neuroscience Ltd

Manufacturer

1 Basic UDI-DI·1 Device·1 Importer

B4C System - Wireless Sensor External Battery (Model: BcSs-BAT-1000 or BcSs-BATEX-1000)

FDA registration

BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.·1 product·🇧🇷 Brazil

B4C System - Wireless Sensor Headband (Model: BcAc-AF-2000)

FDA registration

BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.·1 product·🇧🇷 Brazil

Adapter BcAc-MA-1003

FDA registration

BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.·1 product·🇧🇷 Brazil

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060C22F011·HIP-IPOLY XE-LINER-GROUP C 36MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060D20F011·HIP-IPOLY XE-LINER-GROUP D 36MM +0 FC

465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

FDA registration

BECKMAN COULTER, INC.·2 products·🇺🇸 United States

Trinity Biotech Macra Lp(a)

FDA registration

Trinity Biotech USA·2 products·🇺🇸 United States