8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ABACUS 5
FDA 510(k)
FDA Class 2
·Hematology
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTODIMER ASSAY MODEL # 1431
FDA 510(k)
FDA Class 2
·Hematology
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·May 14, 2013
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·NORTH HAVEN - USS·Product code MFJ·August 11, 2008
AVEA
FDA Adverse Event
CAREFUSION 207, INC.·Product code CBK·May 30, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021