ASSY, SPAR MOUNT, SSXT, JP RAIL

FDA UDI

MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430114779·

Intica Neo 5 HF-T QP

FDA UDI

BIOTRONIK SE & Co. KG·04035479156923·

Ilivia Neo 7 HF-T QP

FDA UDI

BIOTRONIK SE & Co. KG·04035479156725·

Vbeam Prima Base Laser System, JP

FDA UDI

Candela Corporation·00817495023281·Pulsed Laser

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T/QP, Evity 8 HF-T/QP,Evity 8 HF-T/QP, Corox (ProMRI) OTW 85 BP, L85 BP, S 85 BP, Sentus (Pr

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evity 8 F-T QP, Evity 8 HF-T, Enticos 8 HF-T QP, Enticos 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Edora 8 HF-T QP, Edora

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, and En

MicroScan LabPro Connect V5.0 System DVD Kit (JP)

Device

EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·Not intended for eu market

HANA SSXT- AA THA UNIT, MOT, JP RAILS

Device

EU MDR · Eu Md Class 1 ·Mizuho Orthopedic Systems, Inc.·On the market

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·INVENTRA CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM