Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241020584·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241020720·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241021055·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241020645·DyeVert Plus EZ Contrast Reduction System

DYEVERT™ PLUS EZ

FDA UDI

OSPREY MEDICAL INC.·00815241021048·DyeVert Plus EZ Contrast Reduction System.

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS

Medisono

FDA UDI

Medisono, LLC·B369MUS05180·Probe

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T

Lumax

FDA registration

BIOTRONIK, INC.·7 products·🇺🇸 United States

Lumax

FDA registration

BIOTRONIK SE & CO. KG·7 products·🇩🇪 Germany

Tissue Graft Of 6mm And Greater

FDA classification

FDA Class 3 ·Tissue Graft Of 6mm And Greater

Enzyme Immunoassay, Fetal Fibronectin

FDA classification

FDA Class 3 ·Enzyme Immunoassay, Fetal Fibronectin

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States

PRO-TECH DESIGN & MFG., INC.

FDA registration

PRO-TECH DESIGN & MFG., INC.·7 products·🇺🇸 United States