7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WavelinQ Generator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TETRIS SPINAL IMPLANT
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
12X100MM KII OPTICAL ACCESS SYSTEM THREADED
FDA Adverse Event
Other
·APPLIED MEDICAL·Product code GCJ·August 2, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·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