9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive Reline System
FDA 510(k)
FDA Class 2
·Orthopedic
SOL-CARE SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
VRESELECT CULTURE MEDIUM
FDA 510(k)
FDA Class 2
·Microbiology
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
FDA 510(k)
FDA Class 2
·Radiology
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 29, 2011
XP1 SINGLE SYSTEM DENTAL IMPLANT
FDA Adverse Event
Injury
·KEYSTONE DENTAL·Product code DZE·August 29, 2008
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 23, 2025
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013