51 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
FDA Enforcement
Class II
·Terminated·Orthosensor·October 31, 2012
Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.
FDA Recall
Terminated
·Joerns Healthcare Inc.·Product code FSA·February 21, 2007
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·July 27, 2015
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·July 27, 2015
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·January 13, 2012
Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA.
FDA Recall
Terminated
·Joerns Healthcare Inc.·Product code FSA·January 6, 2006
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·November 11, 2013
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·December 19, 2014
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·December 19, 2014
Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use.
FDA Recall
Terminated
·Sunrise Medical Inc·Product code ITI·November 13, 2006
Sunrise Hoyer Advance Patient lifts
FDA Recall
Terminated
·Sunrise Medical, Inc.·Product code FSA·February 3, 2005
IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC
FDA Recall
Terminated
·Integrated Measurement Systems, Inc.·Product code FRW·January 30, 2007
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
FDA Recall
Terminated
·Sunrise Medical Inc·Product code IOR·February 2, 2009
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·June 26, 2012
Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays)
FDA Recall
Terminated
·Sunrise Medical Inc·Product code ITI·April 23, 2007
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
FDA Recall
Terminated
·Orthosensor·Product code ONN·February 4, 2012
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005
BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale
FDA Recall
Terminated
·Arjo, Inc.·Product code FRW·December 19, 2007
Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005