22 results · 31ms · Sources: EU EUDAMED, 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