16 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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HARMONY LED-1 SURGICAL LIGHTING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496072072·BE YOU TONIC, SIZE M, BLU NAVY, GRADUATED COMPR...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698503·Straight Paltop Equator Abutment Conical H6mm
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023348·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
VOXAR VC, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
PROLITE VL PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Crescendo Meniscal Insert PS 15mm Size 2
FDA UDI
AMPLITUDE SAS·03701089525305·
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 27, 2023
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2022
ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 22, 2013
ARCHITECT TOTAL B-HCG REAGENT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code DHA·April 28, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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