Journey II

FDA UDI

Smith & Nephew, Inc.·00885556687260·MODIFIED TIBIAL BASEPLATE TRIAL - ...

Knee Instruments

FDA UDI

Medacta International SA·07630040798020·Trial Femoral Component #1R with lugs

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI

RESPONSIVE ORTHOPEDICS, LLC·00841973101437·Poly Insert MPCS, Size 1R, 20mm

Oticon

FDA UDI

Oticon A/S·05711584058695·SPEAKER UNIT, 1R 100 MINIFIT NEUTRAL

DJO SURGICAL

FDA UDI

DJO, LLC·00888912114974·SPACER BLOCK, TIBIAL LATERAL 1R 10MM

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI

RESPONSIVE ORTHOPEDICS, LLC·00841973101383·Poly Insert MPCS, Size 1R, 10mm

GMK Total Knee System

FDA UDI

Medacta International SA·07630345729514·Tibial tray fixed cemented # 1+ R

Kyocera Medical Technologies, Inc.

FDA UDI

KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124299·CR Femoral Trial Sz 1 R

Prollenium Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·32 Basic UDI-DIs·32 Devices·1 Importer·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, and NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Muscular VSD Occluder

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta and Trifecta GT surgical Heart Valve

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Septal Occluder and Amplatzer Cribriform Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Patent FOramen Ovale Occluder

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Biocor and Epic Valves

RAND SURGICAL SPONGE

FDA 510(k)

FDA Unclassified ·Unknown

TROPIC AIR HEAT-ECHANGER BREATHING AID

FDA 510(k)

FDA Class 2 ·Anesthesiology

Forte MA

FDA registration

XIAMEN NEWSOUND TECHNOLOGY CO., LTD·1 product·🇨🇳 China

Charger 1 miniBTE R (SBO Hearing)

FDA registration

Demant Operations, S.a. De C.v.·1 product·🇲🇽 Mexico