8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
POLYCATH #WMC-900
FDA 510(k)
FDA Class 2
·Cardiovascular
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·January 11, 2013
MICROSTAAR INJECTOR
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code KYB·November 23, 2010
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
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