Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF –T QP, Rivacor 5 HF –T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T (

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 HF -T, Intica Neo 7 and 5 HF -T, Ilivia Neo 7 HF -T QP, and Intica Neo 7 and 5 HF -T QP

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo

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

FDA Pre-Market Approval

FDA Class 3 ·Iperia 7 HF-T (DF-1) Iperia 7 HF-T (DF4) Inventra 7 HF-T (DF-1) Inventra 7 HF-T (DF4) Defibrillator, Automatic Implantab

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Intica Neo 7 HF -T, Intica Neo 7 HF -T QP, BS IS4

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IIivia, 7 HF-T,QP; Intica 7,5 HF-T,QP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

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

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring System