7 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Enforcement
Class II
·Terminated·Atom Medical Corporation·July 18, 2012
Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·May 1, 2012
Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A warmer for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A combination incubator and warmer for infants.
FDA Recall
Terminated
·Atom Medical Corporation 3-18-15 Hongo Bunkyo-Ku Japan·Product code FMZ·August 23, 2011
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020