3 results
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7ms
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Sources: EU EUDAMED, US FDA
ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
FDA Enforcement
Class II
·Terminated·Joerns Healthcare·June 6, 2018
P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
FDA Enforcement
Class II
·Terminated·Joerns Healthcare·June 6, 2018
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