16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Theradome LH40
FDA 510(k)
FDA Class 2
·Physical Medicine
GRAFTING SUCTION
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896009721·GRAFTING SUCTION
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453196·CCR Titanium Medial Blade
24x60m...
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 20, 2022
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 20, 2022
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 20, 2022
SPECTRAL OCT/SLO
FDA 510(k)
FDA Class 2
·Ophthalmic
SMARTLUX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARROR STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 27, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
MICRO DRIVER RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MAF·September 25, 2008
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017