List view Cards view
Name Classification Manufacturer Risk Class Country Source
Ellipse (model CD 2377 - 36 QC) St. Jude Medical Co., Ltd. Japan PMDAJ
(1) Evera ICD series (EveraXT ICD DR IS 1 / DF 1 DDBB 2 D 1) (2) Evera ICD series (EveraXT ICD VR IS 1 / DF 4 DVBB 2 D 4) (3) Evera ICD series (Evera XT ICD DR IS 1 / DF 4 DDB B 2 D 4) Japan Medtronic Co., Ltd. Japan PMDAJ
(1) Marathon Flow Direct Microcatheter (2) MTI Hydrophilic Guide Wire Cardiovascular Devices Covidien Japan Co., Ltd. Japan PMDAJ
(2) Fortify-Assura (CD 1259-40, CD 1259-40 Q, CD 2259-40, CD 2259-40 Q, CD 1359-40, CD 1255-40, (3) Heart Minder ST (CD 1299-40, CD 1299-40 Q, CD 2299-40, CD 2299-40 Q, CD 2259-40, (5) Unify (CD3235-40, CD3235-40Q) (6) Unify Assura (CD 3361-40, CD 3361-40C) (4) Heart Minder + (CD 1391-40C, CD 1391-40 QC, CD 2391-40 C, CD 231-40 QC) (8) QUADORA ASSURA (CD 3367-40, CD 3367-40C, CD 3367-40Q, CD 3367-40 QC) (9) Excelis CRT (CD3367-40, CD3367-40QC) (7) Unified Quadra (CD3251-40, CD3251-40Q) (11) Exelis + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (11) Excises + CRT-D (CD3389-40C, CD3389-40Q, CD3389-40QC) (10) Quadra + Excellis (CD3385-40C, CD3385-40Q, CD3385-40QC) (12) Exelis Quadra (CD 3281 - 40, CD 3281 - 40 Q) St. Jude Medical Co., Ltd. Japan PMDAJ
Semi-automatic defibrillator TEC-2500 series cardiolife S Nihon Kohden Corporation Japan PMDAJ
Baxter in fuser Baxter Corporation Japan PMDAJ
Taiga guiding catheter Cardiovascular Devices Japan Medtronic Co., Ltd. Japan PMDAJ
Intercatheter pacing catheter INTER NOVA CORPORATION Japan PMDAJ
Jarvik 2000 Implantable artificial heart system Century Medical Co., Ltd. Japan PMDAJ
(1) Mella HP Excellan Prime (Model HPO - 06 RHF - C, HPO - 06 H - C) (2) Mella HP Excellan TPC (Model: HPO - 06 RHF - CP, HPO - 06 H - CP) (3) Mella Excel Line Circuit N 2 (4) Mella Exceline Circuit TPC (5) Mella Excel Line Circuit HP 2 Izumi Kogyo Kogyo Co., Ltd. Japan PMDAJ
Hanako · IR catheter Hanako Medical Co., Ltd. Japan PMDAJ
Cardiac rescue RQ - 5000 Japan Lifeline Co., Ltd. Japan PMDAJ
(1) Platinium ICD (2) Platinium CRT-D Japan Lifeline Co., Ltd. Japan PMDAJ
(1) Diagnostic X-ray device X'sy Pro (2) X-ray imaging table BK-1 T (3) X-ray imaging table BK-1 TM Shimadzu Corporation Japan PMDAJ
(1) Automatic biochemical analyzer CA - 400 (2) Automatic biochemical analyzer CA - 400 plus Furuno Electric Co., Ltd. Japan PMDAJ
(1) Medtronic CareLink Monitor 2490C (2) Medtronic CareLink Express Monitor Japan Medtronic Co., Ltd. Japan PMDAJ
Cellvizio 100 system INCREASE INC. Japan PMDAJ
Kids Crown Morita Corporation Japan PMDAJ
Toshiba MRI Vantage Titan 3T MRT-3010 Toshiba Medical Systems Co., Ltd. Japan PMDAJ
Sterilized surgical nonwoven fabric product Medline · Japan LLC Japan PMDAJ
Advance LP PTA balloon expandable catheter Cook Japan Co., Ltd. Japan PMDAJ
Monodiox Alfresa Pharma Co., Ltd. Japan PMDAJ
AO Matrix Mandible system Johnson & Johnson Co., Ltd. Japan PMDAJ
MR contrast agent injection device Sonic shot 7 Nemoto Koryo Hall Co., Ltd. Japan PMDAJ
(1) Dimension Vista 500 (2) Dimension Vista 1500 Siemens Healthcare Diagnostics Co., Ltd. Japan PMDAJ