10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WILTEK GRASPING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CURITY URETERAL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POST-AURICULAR HEARING AID MODEL PE 600PPCH
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X380MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 14, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 25, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 5, 2010
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 20, 2012
ALARIS PUMP MODULE SET NON-VENTED BLOOD SET
FDA Adverse Event
Malfunction
·Product code FPA·June 29, 2021
BD ALARIS¿ LVP BLD180M 15D SS
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 30, 2020
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