8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BABY E.T. TAPE(TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
XLX
FDA UDI
Nuvasive, Inc.·00887517945174·XLX ACR Blade Clip, Posterior
OTIS Optical Coherence Tomography System
FDA 510(k)
FDA Class 2
·Radiology
PROVENT NASAL DILATOR, MODEL BR2
FDA 510(k)
FDA Class 2
·Dental
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 16, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 15, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 13, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021