3,568 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS - Automated Breast Ultrasound System
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS (Automated Breast Ultrasound System) 2.0
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS Autoated Breast Ultrasound System
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS Premium, Invenia ABUS Prime
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS 2.0 Automated Breast Ultrasound System
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·i-FACTOR Peptide Enhanced Bone Graft