14 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VORTRAN Manometer
FDA 510(k)
FDA Class 2
·Anesthesiology
BD LUER-LOK¿ SYRINGE STERILE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 24, 2023
BD 50ML LEUR-LOK SYRINGE
FDA Adverse Event
BECTON DICKINSON AND COMPANY·Product code FMF·February 24, 2023
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
FDA 510(k)
FDA Class 2
·Orthopedic
UNITED U2 XPE TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·January 7, 2016
INTELLISPACE CARDIOVASCULAR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code LLZ·December 3, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
VIVA QUAD XT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 7, 2011
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·May 24, 2016
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023