90 results · 33ms · Sources: EU EUDAMED, 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