2,412 results · 37ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, and Rivacor 5 VR-T

Trilogy Analyzer

FDA registration
JAS Diagnostics/Drew Scientific·7 products·🇺🇸 United States

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF-

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF

Alkaline Picrate, Colorimetry, Creatinine

FDA classification
FDA Class 2 ·Alkaline Picrate, Colorimetry, Creatinine

Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control

DGS Diagnostics A/S

Authorized representative
🇩🇰 Denmark·4 Manufacturers

Piccolo General Chemistry 6

FDA UDI
ABAXIS, INC.·EABA40000061·The Piccolo® General Chemistry 6 , used with th...

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEVICE CARELINK ENCORE 29901 PROGRAMMER INCLUDING ACCESSORIES AND REVEAL DX, REVEAL XT (MODEL SW007 V8.0)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARELINK PATIENT MONITOR 2490G, CARDIOSIGHT READER, CARELINK EXPRESS, REVEAL DX/XT, REVEAL LINQ INSERTABLE CARDIAC MONIT

XL-400

FDA registration
JAS Diagnostics/Drew Scientific·8 products·🇺🇸 United States

Determine HIV Early Detect

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

EDTA Capillary Tubes

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Determine HIV Controls

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Chase Buffer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Wire, Guide, Catheter, Exempt

FDA classification
FDA Class 2 ·Wire, Guide, Catheter, Exempt

SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer

FDA 510(k)
FDA Class 2 ·Orthopedic