151 results · 19ms · 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 for the TLilQ System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK(TM) ECD

THERMASCAN

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Anular Closure Device (ACD)

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·BARRICAID ANULAR CLOSURE DEVICE (ACD)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CELT ACD Vascular Closure Device

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PROTECTA ICD AND PROTECTA XT ICD

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CELT ACD PLUS Vascular Closure Device

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2202.U and NEO 2202.U

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE