Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIME-LITE

FDA UDI

PULPDENT CORPORATION·D701LIME2·Kit: 4 x 1.2 mL syringes + 8 applicator tips Li...

LIME-LITE

FDA UDI

PULPDENT CORPORATION·D701LIME32·3 mL syringe Light cure cavity liner

NuSmile NeoMTA

FDA UDI

NUSMILE, LTD.·00862487000320·Tricalcium silicate-based cement for contact wi...

Hydroxy Vitamin D (25-OH-D) Detection Kit(Fluorescence Immunoassay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

eXero

FDA registration

LODOX SYSTEMS (PTY) LTD.·1 product·🇿🇦 South Africa

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)

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

ExiPrep™ 48 Viral RNA Kit

FDA registration

BIONEER CORPORATION·1 product·🇰🇷 South Korea

Exicycler™ 96

FDA registration

BIONEER CORPORATION·1 product·🇰🇷 South Korea

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640065108·

N/A

FDA UDI

SHIPPERT MEDICAL TECHNOLOGIES, INC·00812185030747·

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640056700·

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640056694·

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640056793·

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640056748·

SUMMIT MEDICAL

FDA UDI

Summit Medical, Inc.·00385640066907·