2,354 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 8, 2016
MERIDIAN GAMMA CAMERA SYSTEM
FDA Adverse Event
Malfunction
·DDD-DIAGNOSTIC A/S·Product code KPS·October 2, 2013
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 26, 2018
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 26, 2018
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·June 13, 2016
INSTRUMENT, ULTRASONIC SURGICAL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 3, 2016
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·December 5, 2019
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWY·December 5, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 5, 2019
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
FDA Recall
Terminated
·Ebi, Llc·Product code LXH·August 13, 2013
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
FDA Recall
Terminated
·Ebi, Llc·Product code HWC·August 22, 2013
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
FDA Recall
Terminated
·Ebi, Llc·Product code NKB·September 16, 2010
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·September 29, 2012
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·February 7, 2013
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
FDA Recall
Terminated
·Ebi, Llc·Product code HXX·September 24, 2013
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Recall
Open, Classified
·EBI, LLC·Product code LOF·March 22, 2024
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Recall
Terminated
·Ebi, Llc·Product code MAX·April 9, 2013