8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
STERILE HYPOALLERGENIC SURGEONS' GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
FORCEPS-ORTHOPEDIC
FDA 510(k)
FDA Class 1
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 22, 2014
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 20, 2012
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; 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