8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ROLLER KNIFE-TRANSVERSE -SAGITTAL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
YASARGIL PERM MINI-CLIP SLT-CVD 4.7MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code HCH·February 19, 2014
INSORB ABSORBABLE STAPLE, MODEL SP-B20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADD-VANTAGE ADDAPTOR
FDA 510(k)
FDA Class 2
·General Hospital
GYNECARE X-TRACT MOTOR DRIVE UNIT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·May 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012
DC BEAD
FDA Adverse Event
Death
·BIOCOMPATIBLES UK LTD·Product code HCG·May 22, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018