9 results
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25ms
·
Sources: EU EUDAMED, US FDA
SMT-100X
FDA 510(k)
FDA Class 2
·Radiology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909119752·REVELATION DIAMOND 801-023SC - 5 PACK
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
FDA 510(k)
FDA Class 2
·Dental
HORIZON OUTLOOK WITH DOSECOM
FDA 510(k)
FDA Class 2
·General Hospital
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 1, 2010
AFFINITY HFO W/TRILLIUM 511T
FDA Adverse Event
Malfunction
·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·January 11, 2013
PEG FULL THREAD 2.5X24MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HRS·July 3, 2014
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 21, 2015
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