8 results
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18ms
·
Sources: EU EUDAMED, US FDA
DEXTRA PRECISION POWER SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209120727·KIT, M-FAK - ODG - CUSTOM
Cryocare CS Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Swoop® Portable MR Imaging® System
FDA 510(k)
FDA Class 2
·Radiology
ZIMMER TM CANNULATED REAMER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·April 4, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 5, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 18, 2015
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024