3 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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Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·March 21, 2011
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2, 15.0 mm; Ref 96-0512.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015