10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MEDELAS BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
FDA 510(k)
FDA Class 1
·Dental
LC BRACKET ADHESIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 29, 2015
TELIGEN DUAL CHAMBER ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code LWS·December 30, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
FREEDOM CONSTRAINED MODULAR HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·August 6, 2018
FREEDOM RINGLOC CONSTRAINED LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·August 6, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024