7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CarboClear Cervical Cage System, CarboClear Cervical VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
FDA 510(k)
FDA Class 1
·General Hospital
OPTIFLO INJECTION NEEDLE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KOG·November 6, 2008
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·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