9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CORDIS PEEL-AWAY INSERTION TOOL
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756372237·GYN PACK
MYLABGOLD
FDA 510(k)
FDA Class 2
·Radiology
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
UNKNOWN STRATA SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·November 22, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 2, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 4, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015