Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT

Salvin DEF 23 German Stainless Steel Extraction Forcep

FDA UDI

Salvin Dental Specialties, Inc.·00841336101166·

Salvin DEF 151AS German Stainless Steel Extraction Forcep

FDA UDI

Salvin Dental Specialties, Inc.·00841336101470·

12Pin 12-Lead Host Cable,AHA,Def-P

FDA UDI

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004433·

12Pin 3-Lead ECG Host Cable,Def-P

FDA UDI

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004426·

6Pin 3-Lead ECG Host Cable,Def-P

FDA UDI

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004136·

Salvin DEF 150AS German Stainless Steel Extraction Forcep

FDA UDI

Salvin Dental Specialties, Inc.·00841336101463·

Intraoral Scanner

Basic UDI-DI

EU MDR · Eu Md Class 1 ·DOF Inc·1 device

Intraoral Scanner

Basic UDI-DI

EU MDR · Eu Md Class 1 ·DOF Inc·1 device

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EFAI PACS Picture Archiving and Communication System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI RTSuite CT HN-Segmentation System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

FDA 510(k)

FDA Class 2 ·Radiology

VITROS Calibrator Kit 24

FDA registration

ORTHO-CLINICAL DIAGNOSTICS, INC.·3 products·🇺🇸 United States

Quantia Ferritin Calibrators (LN 6K49-02, 6K49-04)

FDA registration

ABBOTT LABORATORIES·3 products·🇺🇸 United States

VITROS Calibrator Kit 24

FDA registration

Ortho Clinical Diagnostics, K.K.·3 products·🇯🇵 Japan