13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLEXGUARD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070924·MISS RELAX 140 OPEN TOE, SIZE L, NERO, GRADUATE...
TETRIS 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844002315·The basic shape of the KIMBA®, KIMBA® mini, MOB...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P07092470·7mm PLIF Implant 9mm Wide 24mm Length, 7 deg Lo...
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 26, 2020
MODIFICATION TO PLUM XL INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
CUSTODIOL HTK SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LARGE SUTURECUT NEEDLEDRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 22, 2013
UNKNOWN TRIATHLON TS SIZE 5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 19, 2011
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 2008
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022