9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FPC HIP STEM COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)
FDA 510(k)
FDA Class 2
·Microbiology
UST-969-5 CONVEX TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 20, 2019
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 8, 2021
ARROW EPIDURAL CATHETERIZATION KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code CAZ·May 28, 2014
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·January 9, 2013
TRIDENT 10 X3 INSERT 32MM ID
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code JDI·November 17, 2010
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