2,454 results · 19ms · Sources: EU EUDAMED, US FDA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA® Redensity, RHA®2, RHA®3 and RHA® Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA 3 Mepi

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA 2, RHA 3, RHA 4 Dermal Fillers

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY

FDA 510(k)
FDA Class 3 ·Cardiovascular

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES, ACRYSOF RESTOR INTRAOCULAR LENSES

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval
FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval
FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® AED G3 Pro

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENSES