Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·The 4Kscore Test

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·4Kscore Test

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval

FDA Class 3 ·Et Control

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA FAMILY OF LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed