943 results · 19ms · Sources: EU EUDAMED, US FDA

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·AED 3 BLS Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·BLU-U Blue Light Photodynamic Therapy Illuminator

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE ICD SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF CRT-D SYSTEM