20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
RMO
FDA UDI
Rmo, Inc.·00885797100085·QUAD HELIX ASST 5
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 15, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK USA, INC.·Product code KWP·October 30, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 26, 2020
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 30, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 14, 2020
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 30, 2018
0.8% RESOLVE PANEL B FOR GEL
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·May 2, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS INC·Product code LYJ·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 8, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2021
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 14, 2019
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 8, 2017
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 19, 2019
BD SYRINGE 3ML HEPARIN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019
Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.
FDA Recall
Terminated
·Theken Spine Llc·Product code KWQ·July 29, 2010