12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
LifeGlobal Micro Tips
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UniTip Catheter
FDA UDI
Unisensor AG·07640172971376·
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUNAR IDXA
FDA 510(k)
FDA Class 2
·Radiology
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 26, 2016
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014
V.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·June 5, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 11, 2021
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014