12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131287960·ALTA2 PRO, DESIGNRITE 10 WL MOP
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 30, 2023
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 10, 2002
ZIROX
FDA 510(k)
FDA Class 2
·Dental
STERIGAGE MODEL 1243RA, 1243RB, 1243RE
FDA 510(k)
FDA Class 2
·General Hospital
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·July 30, 2024
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 8, 2014
TRAUMACEM CEMENT KIT
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NDN·June 6, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014