11 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTEBRON PSS PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106105·HOSKIN #16 FORCEPS CURVED
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981255626·Paddle Distractor, 16mm
REDON SET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THE UNI-CLIP STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 10, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 19, 2008
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·April 12, 2011
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