12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Single-Piece PMMA Posterior Chamber IOL
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Single-Piece PMMA Anterior Chamber IOLs
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·INTEGRITY AFX DR MODEL 5346
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·INTEGRITY AFX DR MODEL 5346
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03..
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP