1,556 results · 20ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 6837 & 6839 INDUCTION/MONITOR & 6871 O-RINGS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AV PLUS DX, MODEL 1368

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·ADX PULSE GENERATOR

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY DR & DC; ENTITY DR & DC

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR MODEL 5346

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO