13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TKO Composite Bite Turbo Gel
FDA 510(k)
FDA Class 2
·Dental
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744918·Aufricht Glabella Rasp 8-1/4" (20.6cm), head cu...
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551039488·ROSA BUSHING FOR sEEG, SHORT - NON-STANDARD, FO...
Graseby
FDA UDI
ICU MEDICAL, INC.·00610586100508·
DUAL LUMEN MIDLINE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
CLEAR+BRILLIANT LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
COREVALVE SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CORONARY AND STRUCTURAL HEART·Product code NPT·April 24, 2017
THERMOPHORE AUTOMATIC HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT·Product code IRT·August 8, 2014
ATRIAL CATH BAR TYPE E
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·August 9, 2011
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·July 8, 2013
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Checkvalve Set for secondary (piggyback) Administration described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C4220 (Reorder No. 21-0349-25) for product distributed Internationally. Model Number 8C4220 (Reorder No. 21-0328-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004