1,190 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WeCare Response Bed
FDA UDI
JOERNS HEALTHCARE, LLC·00810055880577·KIT, WECARE BED-QTR OAK-F025
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WeCare Response Bed
FDA UDI
JOERNS HEALTHCARE, LLC·00810055880584·KIT, WECARE BED-QTR OAK-F025-PV BASIC
WeCare Response Bed
FDA UDI
JOERNS HEALTHCARE, LLC·00810055880614·KIT, WECARE BED-QTR OAK-F025-PV CONSOLE
WeCare Response Bed
FDA UDI
JOERNS HEALTHCARE, LLC·00810055880591·KIT, WECARE BED-QTR OAK-F025-BC DERMATEC
WeCare Response Bed
FDA UDI
JOERNS HEALTHCARE, LLC·00810055880607·KIT, WECARE BED-QTR OAK-F025-NYLON BASE
EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·September 1, 2021
MYSPINE S2-SI LEFT GUIDE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code QSR·May 5, 2023
Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
EZ-IO 25MM NEEDLE (BOX OF 5)
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·November 18, 2020
CNS-9700A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·February 12, 2016
EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU)
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·October 12, 2021
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·March 18, 2025
EZ-IO 25MM NEEDLE (BOX OF 5)
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·December 3, 2020
EZ-IO 25MM NEEDLE SET + STABILIZER(BOX O
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·October 24, 2019
EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·April 19, 2021
EZ-IO 45MM NEEDLE + STABILIZER BX/5 (EU)
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FMI·May 4, 2021
ULTRA THIN LONG SUPER WITH WINGS PANTILINER
FDA Adverse Event
Injury
·WALGREENS·Product code HHD·November 5, 2008