Bleckmann UK

FDA registration

Bleckmann UK·3 products·🇬🇧 United Kingdom

SunFit Lamp

FDA registration

ULTRASUN·1 product·🇳🇱 Netherlands

FDA Pre-Market Approval

BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD

SPHYGMOCOR MX MODEL SCOR-MX

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens

OLV VISICAT + TRAY

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ippi srl·10 devices

Addenbrooke/Owa Grommet

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Exmoor Plastics Limited·1 device

STEREOTACTIC BODY FRAME, MODEL COD. 70-1A

FDA 510(k)

FDA Class 2 ·Radiology

MINIOX IV PORTABLE PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIOX 100 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOPOGRAPHIC IMAGING MARKER

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGABLE BRAIN BIOPSY CANNULA SET

FDA 510(k)

FDA Class 2 ·Neurology

MINIOX V PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHADOWFORM

FDA 510(k)

FDA Class 2 ·Radiology

MDT Navigable Brain Biopsy Cannula

FDA 510(k)

FDA Class 2 ·Neurology