156 results · 18ms · Sources: EU EUDAMED, US FDA

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNX ACE VASCULAR CLOSURE DEVICE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE Header, Epicardial Patch Lead

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT HBE (RDNA) EIA TEST KIT

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNXGRIP AND MYNX ACE VASCULAR CLOSURE DEVICE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·digene HC2 High Risk HPV DNA Test

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MynxGrip and Mynx Ace Vascular Closure Device

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MynxGrip, Mynx Ace Vascular Closure Device (VCD)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/PATCH LEAD/LEAD END PIN CAP

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·digene Hybird Capture 2 (HC2) HPV DNA Test

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE