10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Modular Medical MODD1 Insulin Delivery System
FDA 510(k)
FDA Class 2
·General Hospital
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183907·Integra® Jarit® Spinal Fusion Curette, Reverse ...
MFCD 2320
FDA 510(k)
FDA Class 2
·Radiology
S.E.A.L. FRACTURE FUSION TUBE
FDA 510(k)
FDA Class 2
·Orthopedic
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 28, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 28, 2013
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·September 9, 2011
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·November 4, 2014
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024