15 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACID ETCHED LAG SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070955·MISS RELAX 140 OPEN TOE, SIZE L, CAMEL, GRADUAT...
PLACER MODEL 6232 STEERABLE STYLET
FDA 510(k)
FDA Class 2
·Cardiovascular
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 23, 2025
5.5MM SHORT SECONDARY PORT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC·Product code GCJ·April 1, 2013
CCO CATHETER INTERFACE CABLE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·July 3, 2008
MESH-COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·April 19, 2011
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
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