39 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ArgenZ HT+ 95x25 A3.5
FDA UDI
ARGEN CORPORATION, THE·D818122793·Dental porcelain/ceramic restoration kit
TETRIS SPINAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Z-LOOK3 EVO SLM
FDA 510(k)
FDA Class 2
·Dental
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 21, 2013
TOTAL ASR FEB IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 13, 2008
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·May 12, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 25, 2017
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·January 16, 2019
Ureteral dilator, REF RBD014
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 10, 2024
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 8, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 7, 2017
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·August 27, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 24, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 18, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·July 25, 2018
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 12, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·January 15, 2020