8,122 results · 55ms · Sources: EU EUDAMED, US FDA

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Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator

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 ·HeartStart FRx Defibrillator (861304)

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart Home Defibrillator and HeartStart OnSite Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite and Home Defibrillator

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator

TinniLogic Mobile Tinnitus Management Device

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)
FDA Class 2 ·Dental

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917021936·ACIS PROTI 10 DG HL M 8MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022261·ACIS PROTI 12 DG HL L 10MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022186·ACIS PROTI 10 DG HL L 8MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022674·STD 12 DG 10 AND 11 MM H TRL

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022407·ACIS PROTI 10 DG HL X 7MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917021974·ACIS PROTI 10 DG HL M 12MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022865·LG 20 DG 11 AND 12 MM H TRL

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022421·ACIS PROTI 10 DG HL X 9MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022650·STD 12 DG 6 AND 7 MM H TRL

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022339·ACIS PROTI 15 DG HL L 11MM H

ACIS® ProTi 360™ HL

FDA UDI
Tyber Medical LLC·00819917022216·ACIS PROTI 10 DG HL L 11MM H