20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Selectra Catheters and Selectra Accessory Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087517·
ECHO FX HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304520295·
BD SYRINGE 5ML LL SP125
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 6, 2025
SLIVASURE
FDA 510(k)
FDA Class 1
·Hematology
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWA·July 6, 2021
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2013
SELUTE PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 4, 2008
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 7, 2025
BD SYRINGE 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2025
BD SYRINGE 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2025
BD SYRINGE 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 25, 2025
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
UNK HAKIM PROGRAMMABLE VALVE
FDA Adverse Event
Injury
·Product code JXG·November 14, 2017
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016