1,160 results · 22ms · Sources: EU EUDAMED, US FDA

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)

Automated External Defibrillators (Non-Wearable)

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

Automated External Defibrillators (Non-Wearable)

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

Automated External Defibrillators (Non-Wearable)

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

Automated External Defibrillators (Non-Wearable)

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

Automated External Defibrillators (Non-Wearable)

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

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SAV AORTIC PORCINE BIOPROSTHESIS

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE™ Bone Graft/Medtronic Interbody Fusion Device

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE™ Bone Graft

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·INFUSE™ Bone Graft

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI SURESCAN

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION DEVICE FITTING SOFTWARE (SCLIN)