24 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ODISSEY TISSUE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868247972·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558689·
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304008328·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T1412340·14mm TLIF Implant 12mm Wide 34mm Length
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T14123470·14mm TLIF Implant 12mm Wide 34mm Length 7 Degrees
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA 510(k)
FDA Class 1
·Microbiology
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025
AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024
NEEDLE SFTYGLD 25X1 RB MCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·June 7, 2021
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151542·14 X 12 CERVICAL TRIALS 34MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151733·14 X 12 CERVICAL TRIALS 34MM 10° LORDOSIS
AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026
AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026
KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 3, 2013
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·October 3, 2014