2,412 results · 48ms · Sources: EU EUDAMED, US FDA

DGS Diagnostics A/S

System producer
🇩🇰 Denmark

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256,

PICCOLO 9-CHEM REAGENT ROTOR

FDA registration
ABAXIS, INC.·9 products·🇺🇸 United States

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S

Abbott Rapid Dx International Limited

Importer
🇮🇪 Ireland·11 Manufacturers

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Piccolo Basic Metabolic Panel

FDA UDI
ABAXIS, INC.·EABA40000241·The Piccolo® Basic Metabolic Panel, used with t...

Piccolo MetLyte 8 Panel

FDA UDI
ABAXIS, INC.·EABA40000231·The Piccolo® MetLyte 8 Panel, used with the Pic...

Care Surgical Supplies Limited

Authorized representative
🇮🇪 Ireland·2 Manufacturers·371 Devices

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

Piccolo MetLyte Plus CRP

FDA UDI
ABAXIS, INC.·EABA40000341·The Piccolo® MetLyte Plus CRP reagent disc, use...