62 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Recall
Terminated
·TERRIFIC CARE LLC
61 Willet St
Bldg A-1, Fl 2
Passaic NJ 07055-1971·Product code GJS·December 20, 2018
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Recall
Terminated
·Linde Gas North America Llc
575 Mountain Ave
Attn Import Compliance Manager
New Providence NJ 07974·Product code CAN·March 8, 2013