9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044201222·Sterile 30 mL Conical Centrifuge Tubes with Caps
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Overjet Calculus Assist
FDA 510(k)
FDA Class 2
·Radiology
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·November 4, 2014
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026