8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150768·K-WIRE - SINGLE TROCAR 1.6mm DIA x 230mm
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
FDA 510(k)
FDA Class 1
·Radiology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 3, 2010
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
PALIND 28/45 SLOT KIT W/VT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·December 7, 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