GMK Primary Total Knee System

FDA UDI

Medacta International SA·07630030816178·Full-PE PS Tibial Component #1/17

GMK Primary Total Knee System

FDA UDI

Medacta International SA·07630030817885·Tibial insert STD fixed 14mm, size 4

GMK Sphere Total Knee System

FDA UDI

Medacta International SA·07630030826382·Tibial Insert Fixed SPHERE Flex #3/12 mm R

GMK Revision Total Knee System

FDA UDI

Medacta International SA·07630030814792·Femoral wedge posterior 5mm, size 2

GMK Revision Total Knee System

FDA UDI

Medacta International SA·07630030822803·Extension stem Ø22mm, 150mm

GMK Sphere Total Knee System

FDA UDI

Medacta International SA·07630030826375·Tibial Insert Fixed SPHERE Flex #3/12 mm L

GMK Primary Total Knee System

FDA UDI

Medacta International SA·07630030817236·Tibial insert UC fixed 14mm, size 3

GMK Sphere Total Knee System

FDA UDI

Medacta International SA·07630971261051·Tibial Insert Fixed SPHERE CR #1/11 mm L E-cross

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)

FDA 510(k)

FDA Class 2 ·Orthopedic

Electrical Neuromuscular Stimulator, Cure Trio

FDA 510(k)

FDA Class 2 ·Neurology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMPLETE BRAND LUBRICATING AND REWETTING DROPS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (FICDx)

MEDILET

FDA registration

TIANJIN HUAHONG TECHNOLOGY CO LTD·3 products·🇨🇳 China

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

XactTrace Single Use Respiratory Effort Belt System

FDA 510(k)

FDA Class 2 ·Anesthesiology

THERAPLAN PLUS VERSION 1.2

FDA 510(k)

FDA Class 2 ·Radiology

EMBLETTA MPR

FDA 510(k)

FDA Class 2 ·Anesthesiology