22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REGENEREX TIBIAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Regent
FDA UDI
SPINAL ELEMENTS·00840916114978·Regent ACP 3-Level, 61mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450388075·
NA
FDA UDI
STRYKER CORPORATION·07613327058338·Insert, Bipolar Paddle Forceps
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
FDA 510(k)
FDA Class 2
·Neurology
K-ASSAY AT-III
FDA 510(k)
FDA Class 2
·Hematology
XIA LP POLYAXIAL SCREW 6.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
XIA ROD DIA. 6 X 480
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011
XIA BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2024
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
XIA LP POLYAXIAL SCREW 5.5 X 45MM
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016
XIA POLYAXIAL SCREW 8.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011
XIA BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011
4.0MM HEXAGONAL SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·April 26, 2013
GENESIS PULSE GENERATOR, DUAL 4 CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011
GE OEC 8800 FLEXIVIEW
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 24, 2008
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 16, 2019
XIA LP POLYAXIAL SCREW 6.5 X 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 6, 2013