7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
FDA 510(k)
FDA Class 2
·General Hospital
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
FDA 510(k)
FDA Class 2
·Anesthesiology
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
FDA 510(k)
FDA Class 2
·Orthopedic
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
*
FDA Adverse Event
Malfunction
·OLYMPUS CORPORATION OF THE AMERICAS·Product code GEI·July 3, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024