14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLIT LAMP SL-2000
FDA 510(k)
FDA Class 2
·Ophthalmic
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 20, 2018
VENOFER PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·August 30, 2019
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·August 30, 2019
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 6, 2023
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MBB·March 11, 2021
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MBB·March 11, 2021
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·June 11, 2013
AVANCE
FDA Adverse Event
Malfunction
·GE DATEX OHMEDA·Product code BSZ·July 11, 2011
ULTRAFLEX COVERED TRACHEOBRONCHIAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·September 17, 2008
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·December 9, 2019
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·October 21, 2020