Sentosa SQ HIV-1 Positive Control Kit

FDA registration

Vela Operations Singapore Pte Ltd·1 product·🇸🇬 Singapore

Sentosa SQ HIV-1 Genotyping Assay

FDA registration

Vela Operations Singapore Pte Ltd·1 product·🇸🇬 Singapore

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

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL

NGH MD

Device

EU MDR · Eu Md Class 2b ·GPI S.P.A.·On the market·1 country

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM, EMBLEM MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INVIVE, INTUA, VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 and NG4 Implantable Cardioverter Defibrillators (ICDs)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs

Electro Lavage MG

FDA UDI

MECTRA LABS, INC.·00817984010846·Electro Lavage MG J Hook Dual Spike

Electro Lavage MG

FDA UDI

MECTRA LABS, INC.·00817984010853·Electro Lavage MG J Hook Double Bottle

Electro Lavage MG

FDA UDI

MECTRA LABS, INC.·00817984010839·Electro Lavage MG J Hook Single Spike

Personal Genome Machine™ Dx (PGM™) Dx

FDA UDI

LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·10190302000833·