2,448 results · 19ms · Sources: EU EUDAMED, US FDA

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator

Sensor, Glucose, Invasive

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORETEC HEARTMATE XVE LVAS

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE, COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLE 17 & 17A POSTERIOR CHAMBER IOLS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SUPERSTAT

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STYLE 17 & 17A POSTERIOR CHAMBER IOLS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCON SEVEN AND SEVEN PLUS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLUMA XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel Pleural Air Leak Sealant

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval
FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator