8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
FDA 510(k)
FDA Class 1
·General Hospital
HI LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SOPHER AND BIERER OVUM FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SLIMLINE SEMI RIGID FORCEP
FDA Adverse Event
Malfunction
·GYRUS ACMI INC.·Product code HIH·May 20, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
SERIES 20000 LEGACY
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 10, 2012
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020