9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sklar®
FDA UDI
SKLAR CORPORATION·10649111168512·CASTRO-FINO NH CVD W/LK 5"
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
FDA 510(k)
FDA Class 2
·Neurology
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ALARIS PUMP MODULE ADMIN SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·June 27, 2014
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 31, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·February 2, 2011
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017