115 results · 23ms · Sources: EU EUDAMED, US FDA

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·RAPID FFN FOR THE TLIIQ SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS I3 Patient Electronics System (PES)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·RAPID FFN CONTROL KIT

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Primary Battery (989803150161)

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval
FDA Class 3 ·LAMICEL(TM)