11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIATION STERILIZED ADMIN. SET
FDA 510(k)
FDA Class 2
·General Hospital
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40428110780·PEEK TLIF Spacer, 28 x 11 x 7mm, 8 deg
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41428110780·Titanium TLIF Spacer, 28 x 11 x 7mm, 8 deg
MALLEABLE SHAFT CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·August 11, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024