10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BLUE POWDERED NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
CONGRUENT BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013
AUTOPULSE LI-ION BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013
CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016