1,530 results · 38ms · Sources: EU EUDAMED, US FDA

Smith & Nephew VISIONAIRE Adaptive Guides

FDA 510(k)
FDA Class 2 ·Orthopedic

Acumen Hypotension Prediction Index (HPI) Algorithm

FDA 510(k)
FDA Class 2 ·Cardiovascular

JOURNEY II XR Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

LUMAX (MODIFICATION)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK

FDA 510(k)
FDA Class 2 ·Cardiovascular

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Aveir™ VR and DR Leadless Pacemakers

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·BRAD E-LUMINEXX VASCULAR STENT SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Micra VR/AV Application

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Platinium VR and Platinium DR ICDs

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·OVATIO VR AND OVATIO DR ICDS

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PARADYM RF VR & RF DR ICD

418.00D grad. probe williamnf14d 3-6-9-11-13-16

Device
EU MDR · Eu Md Class 1 ·Prodont-Holliger·On the market

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SECURA DR/VR & MAXIMO II DR/VR