7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131
FDA 510(k)
FDA Class 1
·Hematology
17HK701G-W
FDA 510(k)
FDA Class 2
·Radiology
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code CGA·October 26, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·December 21, 2012
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020