Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve – AP360

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT AORTIC VALVED GRAFT

CN24/00002692

Certificate

MDR QA·APT Medical Inc.·SGS Belgium NV

CN19/41126

Certificate

MDD Annex II Section 4·APT Medical Inc.·SGS Belgium NV·23 Basic UDI-DIs

CN23/00002940

Certificate

MDR QMS·APT Medical Inc.·SGS Belgium NV

CN19/41142

Certificate

MDD Annex II Section 4·APT Medical Inc.·SGS Belgium NV·8 Basic UDI-DIs

CN19/41145

Certificate

MDD Annex II Section 4·APT Medical Inc.·SGS Belgium NV·10 Basic UDI-DIs

Ti-Diagon Oblique TLIF

FDA registration

CAMBER SPINE TECHNOLOGIES·1 product·🇺🇸 United States

Silhouette Soft Suture, SMS 100 (2 x SMS 22-PL-3.1-NA + 1 x SMS 23-PL-3.1-NA)

FDA registration

SINCLAIR PHARMA US, INC.·1 product·🇺🇸 United States

LPS, Orthogenesis

FDA registration

DEPUY ORTHOPAEDICS, INC.·1 product·🇺🇸 United States

POWER CONSOLE

FDA registration

DEPUY ORTHOPAEDICS, INC.·1 product·🇺🇸 United States

Duraloc (hip)

FDA registration

DEPUY ORTHOPAEDICS, INC.·2 products·🇺🇸 United States

Cement Restrictor

FDA registration

DEPUY ORTHOPAEDICS, INC.·1 product·🇺🇸 United States

IntraMed France SAS

Importer

🇫🇷 France·4 Manufacturers

Asante DNA Specimen Collection Kit

FDA registration

SEDIA BIOSCIENCES CORP.·1 product·🇺🇸 United States

Primaloc Cemented Hip System

FDA registration

ORTHO DEVELOPMENT CORP.·1 product·🇺🇸 United States