Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le

Test, Anti-Tumor Cell Susceptibility

FDA Pre-Market Approval

FDA Class 3 ·BARTELS CHEMORESPONSE ASSAY

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY™XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON™ Everolimus-Eluting Platinum Chr

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, Sphera DR/SR MRI IPG, Astra S DDR/SR MRI IPG, Astra XT DR/S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DDR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prot

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI;

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS/DR/DR-T/VR/DROMOS DR/SR/SL/KAIROS DR/SR/SL/D/S/PHILOS/DR/DR-T/SR/SLR/D/S/PHILOS II D/DR/S/SLR/SR/DR-T/PROTOS DR/CL

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·VISULAS ND:YAG LASER