2,448 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STYLE 17 & 17A POSTERIOR CHAMBER IOLS
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Exact Spinal Sealant
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Dural Sealant System
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·JUVEDERM HYALURONATE GEL IMPLANTS
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Juvederm Injectable Gel Implants
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·TCI HEARTMATE VE LVAS
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·SALINE-FILLED BREAST IMPLANTS
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL DURAL SEALANT SYSTEM
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Solution, Removal, Carries
FDA Pre-Market Approval
FDA Class 3
·GK-101E CARIES REMOVAL AGENT/SYSTEM
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL EXACT SPINE SEALANT SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·NATRELLE Silicone-Filled Breast Implants
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LifeVest Wearable Defibrillator
Sensor, Glucose, Invasive, Non-Adjunctive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY