7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip
FDA 510(k)
FDA Class 2
·Radiology
Alinity m STI Assay
FDA 510(k)
FDA Class 2
·Microbiology
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
FDA 510(k)
FDA Class 2
·Hematology
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA, CINCINNATI·Product code HBL·August 10, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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