9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TUBULAR STOCKINETTE
FDA 510(k)
FDA Class 1
·General Hospital
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127027796·Bipolar Head Trial, Size 42mm
BRM Digitalis Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSCAN SYNERGIES PLUS
FDA 510(k)
FDA Class 2
·Microbiology
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·August 30, 2010
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 22, 2023
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024