50 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARELINK MONITOR MODEL 2490C, MODEL 24950; CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MODEL 2491 DD
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·LIPOSORBER LA-15 SYSTEM