10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex AlloSync PushLock Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
FDA 510(k)
FDA Class 2
·Orthopedic
Atrial Fibrillation History Feature
FDA 510(k)
FDA Class 2
·Cardiovascular
RELION® INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 19, 2018
GIA 60-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·November 14, 2008
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·August 31, 2011
COBAS E411 RACK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·July 18, 2013
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·August 28, 2024
ACCESS HIGH SENSITIVITY TROPONIN I REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·November 2, 2022
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