68 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Dukal Corporation Level 1 Pediatric Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DUKAL CORPORATION
FDA Adverse Event
Injury
·DUKAL CORPORATION·Product code KGX·January 30, 2010
DUKAL CORPORATION
FDA Adverse Event
Injury
·DUKAL CORPORATION·Product code FQM·February 7, 2010
Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUBRICANT, WATER SOLUBLE, TUBE, 2 OZ., 1/PACK
FDA Adverse Event
Injury
·DUKAL CORPORATION·Product code KMJ·August 7, 2024
BURN SHEET
FDA Adverse Event
Malfunction
·DUKAL CORPORATION·Product code FPY·April 19, 2017
REGARD
FDA Adverse Event
Malfunction
·DUKAL CORPORATION·Product code GDY·December 11, 2019
Endura No-React Dural Substitute 6 cm x 10 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
EnDura No React Dural Substitute 10 cm x 12 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
Endura No-React Dural Substitute 2 cm x 10 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
EnDura No-React Dural Substitute 4 cm X 4 cm.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
EnDura No-React Dural Substitute 5 cm x 6 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·May 4, 2007
EnDura No-React Dural Substitute 12 cm Diameter
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code GXQ·January 13, 2010
DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010
DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010