10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Threshold Pedicular Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·April 11, 2019
CARBON DIOXIDE LIQUID STABLE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DELTAFILL10 6MM X 16CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 5, 2021
ACCU-CHEK ® INSIGHT FLEX INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code FPA·March 29, 2017
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARIDOVASCULAR·Product code MIH·September 11, 2008
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024