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

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D

US_Endoscopy4223 (SP) - Defendo Fujifilm 700 series valve kits

FDA registration

ISOMEDIX OPERATIONS INC.·4 products·🇺🇸 United States

Defendo Fujifilm 700 series valve kits

FDA registration

Medivators Inc·4 products·🇺🇸 United States

Defendo Fujifilm 700 series valve kits

FDA registration

UNITED STATES ENDOSCOPY GROUP, INC.·4 products·🇺🇸 United States

CW-4

FDA registration

Gyrus ACMI, Inc.·4 products·🇺🇸 United States

Medivators2752 (PL) - Defendo Fujifilm 700 series valve kits

FDA registration

Isomedix Operations Inc.·4 products·🇺🇸 United States

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

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States

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

FDA registration

Abbott Medical·7 products·🇺🇸 United States

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

FDA registration

Abbott Medical·7 products·🇺🇸 United States

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

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States

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

FDA registration

St. Jude Medical Coordination Center BVBA European Distribution Center·7 products·🇧🇪 Belgium

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

FDA registration

Abbott Medical·7 products·🇲🇾 Malaysia

HL60145538

Certificate

IVDD Annex IV (excluding sections 4, 6)·GB Lifecare Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

Fisher Scientific GTF AB

Importer

🇸🇪 Sweden

Micro Camera

FDA registration

HEBUMEDICAL GMBH·5 products·🇩🇪 Germany

GIF-1100

FDA registration

SHIRAKAWA OLYMPUS CO., LTD.·5 products·🇯🇵 Japan

GIF-1100

FDA registration

OLYMPUS MEDICAL SYSTEMS CORP.·5 products·🇯🇵 Japan

GIF-1100

FDA registration

AIZU OLYMPUS CO., LTD.·5 products·🇯🇵 Japan

IAN JAMIESON PTY LTD

FDA registration

IAN JAMIESON PTY LTD·5 products·🇦🇺 Australia

CDF Medical Equipment Trading LTD

Importer

🇨🇾 Cyprus