20 results · 23ms · Sources: EU EUDAMED, 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