10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Proxeo ULTRA (PB-510, PB-520 and PB-530)
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Medos International Sàrl·20886705030559·FREE NEEDLE LOOP REVERSE CUTTING NEEDLE WITH ST...
ExacTrac Dynamic
FDA 510(k)
FDA Class 2
·Radiology
ANDREWS INTRODUCER, MODEL ASI01
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 25, 2018
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·June 6, 2018
MONOCRYL (POLIGLECAPRONE 25) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·November 4, 2014
ENDURANT AUI STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 12, 2011
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·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