9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
FDA 510(k)
FDA Class 2
·Hematology
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 15, 2019
SAPIENS TIP CONFIRMATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BEAUTIBOND
FDA 510(k)
FDA Class 2
·Dental
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM LARGE TITANIUM LIGA
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDO·October 3, 2008
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 11, 2011
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·June 21, 2013
VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·October 4, 2017
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
FDA Enforcement
Class II
·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025