18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
FDA 510(k)
FDA Class 2
·Anesthesiology
Orbit Depressor
FDA UDI
KATENA PRODUCTS, INC.·00841668100882·SCHEPENS SCLERAL DEPRESSOR SMALL
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM
BAK®
FDA UDI
ZIMMER SPINE, INC.·00889024333321·
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·October 10, 2014
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 31, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2011
OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·September 12, 2025
NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA.
FDA Recall
Terminated
·Boston Scientific Cupertino, Corporation·Product code NIM·May 15, 2006
BLUNT TIP SCREW, ÿ 4X44MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·May 8, 2024
L3C3850 - GENTLECATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KOD·January 21, 2021
L3C3850 - GENTLECATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KOD·January 21, 2021
L3C3850 - GENTLECATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KOD·January 21, 2021
L3C3850 - GENTLECATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KOD·January 21, 2021
L3C3850 - GENTLECATH
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KOD·January 21, 2021
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018