16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIOUS MODELS OF WHEELCHAIRS
FDA 510(k)
FDA Class 2
·Physical Medicine
ReLine
FDA UDI
Nuvasive, Inc.·00195377069023·RELINE C Screw, 4.5x22mm MA
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014735·
MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
FDA 510(k)
FDA Class 1
·General Hospital
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 27, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 27, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 18, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPAEDIC INC.·Product code KWP·October 8, 2009
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 22, 2010
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 4, 2012
Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Prostate Stabilization Set
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code IWJ·September 1, 2009