90 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPRI Corpectomy Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
ClearFit
FDA UDI
LONGEVITI NEURO SOLUTIONS LLC·00855113008135·ClearFit Hemi OTS Right
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100783·FLIERINGA FIXATION RING 17MM
SLEEVE AND BUTTON SOFT TISSUE DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER DTO PIN PRESS INSTRUMENT
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2011
AUTOSUTURE
FDA Adverse Event
Malfunction
·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code GDO·September 11, 2008
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
FDA Enforcement
Class II
·Terminated·SpineFrontier, Inc.·July 24, 2013
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
FDA Recall
Terminated
·SpineFrontier, Inc.·Product code MNI·December 30, 2011
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 15, 2021
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DQX·July 2, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·August 12, 2024
AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·April 25, 2022
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·May 3, 2024
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·June 4, 2024
SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·September 1, 2022
BENTSON STRAIGHT FIXED CORE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 8, 2024
LUNDERQUIST-RING TORQUE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·September 28, 2021
SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 7, 2022