14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PEDICLE SCREW MONOAXIAL SCREW 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·March 31, 2016
FLEXITIME XTREME
FDA 510(k)
FDA Class 2
·Dental
HD-IVUS ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INDIGO SYSTEM ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code QEW·August 7, 2023
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 3, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 20, 2011
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 22, 2019
MUST PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2017
Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.
FDA Recall
Terminated
·GE Healthcare·Product code LLZ·May 1, 2008
PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 4, 2018
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 5, 2017