8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sample Preservative Fluid
FDA 510(k)
FDA Class 2
·Microbiology
BD Difco™ Salmonella H Antiserum z
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902227717·BD Difco™ Salmonella H Antiserum z, 3 mL
TWIN FIX
FDA 510(k)
FDA Class 2
·Orthopedic
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
COULTER® AC *T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 12, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 13, 2015
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