13 results
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29ms
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Sources: EU EUDAMED, US FDA
SHUR GEL
FDA 510(k)
FDA Class 2
·Dental
Persona®
FDA UDI
Zimmer, Inc.·00889024559592·
Persona®
FDA UDI
Zimmer, Inc.·00889024559684·
Persona®
FDA UDI
Zimmer, Inc.·00889024559776·
Persona®
FDA UDI
Zimmer, Inc.·00889024559509·
VAXCEL WITH PASV PORT
FDA 510(k)
FDA Class 2
·General Hospital
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROPLAN CMF
FDA Adverse Event
Injury
·MATERIALISE NV·Product code HWT·May 1, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 13, 2012
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 7, 2010
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·April 4, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·April 4, 2018
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021