8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EZ-STIK Electrodes
FDA 510(k)
FDA Class 2
·Neurology
AIC disposable medical mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RIATA ST OPTIM PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·August 25, 2011
M2A 38MM MOD HD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·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