7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
FDA 510(k)
FDA Class 2
·Cardiovascular
MONDEAL EXTREMITY BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LDL-DIRECT CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 21, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2014
CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·January 21, 2011
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019