Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC Ophthalmic Viscosurgical Device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Ophthalmic Viscosurgical Devices

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR/DR/RHAPSODY SR/DR/REPLY VR/DR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 BLS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 BLS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 BLS Device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL AED 3 BLS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL AED 3 BLS Device

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply/Esprit (5th generation) Electric Hybrid Module

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Belotero Balance(+) Lidocaine Dermal Filler (BBL)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC