16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GC MI PASTE PLUS
FDA 510(k)
FDA Class 1
·Dental
KIMTECH STERLING NITRILE EXAM GLOVES (L)
FDA UDI
KIMBERLY-CLARK GLOBAL SALES, LLC·00036000507089·Examination Gloves
KIMTECH STERLING NITRILE EXAM GLOVES (L)
FDA UDI
KIMBERLY-CLARK GLOBAL SALES, LLC·00036018507088·Examination Gloves
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
FDA 510(k)
FDA Class 1
·General Hospital
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 11, 2021
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 27, 2025
2.0X7MM FOSSA X-DR SCRW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·April 22, 2013
J-VAC RESERVOIR
FDA Adverse Event
Malfunction
·ETHICON·Product code KOG·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·June 6, 2025
HEMOSIL ACUSTAR HIT-IGG (PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·April 8, 2025
HEMOSIL ACUSTAR HIT-IGG(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
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