33 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wet Organics Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780463559·Maloney Intraocular Lens (IOL) Manipulator 4-3/...
Origin Short 125deg Trial Neck
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215081423·
FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
FDA 510(k)
FDA Class 2
·General Hospital
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EASYTOUCH
FDA Adverse Event
Malfunction
·BERPU MEDICAL TECHNOLOGY CO., LTD·Product code FMF·November 20, 2023
1.4 FR SINGLE LUMEN CATHETER
FDA Adverse Event
Malfunction
·FOOTPRINT MEDICAL INC.·Product code LJS·December 30, 2025
IDNOW STREP A KITS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code OOI·March 31, 2026
IDNOW STREP A KITS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code OOI·March 31, 2026
IDNOW STREP A KITS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code OOI·March 31, 2026
IDNOW STREP A KITS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code OOI·March 31, 2026
IDNOW STREP A KITS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code OOI·March 31, 2026
IDNOW STREP A KITS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code OOI·March 31, 2026
CADD PUMP LEGACY
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·December 28, 2022
CER BIOLOXD OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·June 21, 2013
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 22, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 22, 2008
SENSAR IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 3, 2023
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·May 1, 2026
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
FDA Enforcement
Class II
·Ongoing·Contego Medical LLC·October 22, 2025