2,810 results · 47ms · Sources: EU EUDAMED, US FDA

FDA Pre-Market Approval
Altius® Direct Electrical Nerve Stimulation System

FDA Pre-Market Approval
Altius® Direct Electrical Nerve Stimulation System

FDA Pre-Market Approval
Altius Direct Electrical Nerve Stimulation System

FDA Pre-Market Approval
Altius Direct Electrical Nerve Stimulation System

FDA Pre-Market Approval
Altius® Direct Electrical Nerve Stimulation System

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR

FDA Pre-Market Approval
Calcivis Imaging System

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER