18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CORDIS DUCOR PTR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNDE-LOCK SYNDESMOSIS REPAIR KIT
FDA 510(k)
FDA Class 2
·Orthopedic
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
FDA 510(k)
FDA Class 2
·Neurology
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 15, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 17, 2010
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 17, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 16, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 11, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 8, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·March 19, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 8, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2021
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2022
DRETLER UNIVERSAL URETEROSCOPY STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 22, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 9, 2022
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