8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014
FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DXC·September 9, 2011
3.5MM CORTEX SCREW SELF-TAPPING 26MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 23, 2013
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024