7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORPHYRIN TEST AGAR
FDA 510(k)
FDA Class 1
·Microbiology
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
FDA 510(k)
FDA Class 2
·Orthopedic
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 13, 2014
SIG TKA GDE/MDL SET 04-05
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·November 20, 2012
HARMONIC ACE 23CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 22, 2010
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023