10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OTOGRAM, CA3350
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Vial Adaptor
FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108240085·Vial Adapter 13mm ML- Horizontal
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696479·Bone Tap Kit
RAPID PROGRAMMAR
FDA 510(k)
FDA Class 2
·Neurology
NORMED MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 15, 2013
ACRYSOF
FDA Adverse Event
Injury
·ALCON LABORATORIES IRELAND LTD.·Product code HQL·April 22, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
FDA Enforcement
Class II
·Terminated·GE Healthcare·November 18, 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