41 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVON PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743700·ACHIMED ACHILLES SUPP SAND I
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062765·Mini Uni-Twin(TM) Bracket APC(TM) II UL2 8T/9A ...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093783·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL2 8T/9...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016867·Mini Uni-Twin(TM) Bracket UL2 8T/9A .018 5/Pk
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COOL-TEC ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
TRIAL SPACER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTD·March 26, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 16, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·December 13, 2021
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·August 26, 2020
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·August 26, 2020
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·September 9, 2021
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·September 21, 2021
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·September 21, 2021
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·August 6, 2021
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·September 21, 2021