T1040 AKA AURAWAVE

FDA 510(k)

FDA Class 2 ·Neurology

EKA-3065/AA

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

EKA-3080/AA

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

EKA-2080/AA

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

EKA-2065/AA

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

EKA-1080/AA

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

EKA-1065/AA

Device

EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

Sonablate

FDA registration

Focus Surgery, Inc.·1 product·🇺🇸 United States

Sonablate

FDA registration

Focus Surgery, Inc.·1 product·🇺🇸 United States

iNtuition

FDA UDI

Terarecon Inc.·INTUITION5·iNtuition Mobile (aka AQMobile) refers to the c...

Intuition

FDA UDI

Terarecon Inc.·INTUITION11·Intuition Web (aka AquariusWeb Viewer and AqWeb...

SUNGLASSES(NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)

FDA registration

ONNURY OPTICAL CO.·1 product·🇰🇷 South Korea

FRAME, SPECTACLE

FDA registration

ONNURY OPTICAL CO.·1 product·🇰🇷 South Korea

FS-3000

FDA registration

TURBOMED ORTHOTICS INC.·1 product·🇨🇦 Canada

MEDUP HANDHELD DYNAMOMETER

FDA registration

ATLAS MEDIC INC.·1 product·🇨🇦 Canada

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

PASCAL Synthesis

FDA UDI

TOPCON MEDICAL LASER SYSTEMS, INC.·00855005006201·PASCAL Synthesis, ASSY, SLC AND ESF, 577nm, SYN...

PASCAL Synthesis

FDA UDI

TOPCON MEDICAL LASER SYSTEMS, INC.·00855005006195·PASCAL Synthesis, ASSY, SLC AND ESF, 532nm, SYN...

RESTORE (AKA RE/STOR)

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology