13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DSG Threaded Drill System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Logical Reamers Tray (Lower)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076412·
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VISUM BLADE LED SURGICAL LIGHTING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023