34 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
FDA 510(k)
FDA Class 2
·Orthopedic
BD SmartSite
FDA UDI
BD Switzerland Sàrl·10885403235238·Syringe Administration Set, Microbore Tubing, N...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450278536·
SPERMCATCH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
CORTSCR Ø3.5 L26 TI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KWQ·May 3, 2013
LAMITRODE TRIPOLE 16 SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 28, 2011
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 31, 2008
BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 30, 2019
ALARIS SYRINGE MODULE SETS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·April 2, 2020
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·June 26, 2019
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 26, 2019
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 11, 2019
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 7, 2019
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·June 27, 2019
PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·November 21, 2023
BLUNT TIP SCREW, ÿ 4X44MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·November 21, 2023
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·June 17, 2019
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·July 23, 2019