FDA.reportPublic FDA data

Hard-tissue ultrasonic surgical system

Definition
An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.
GUDID devices
165
Last updated
2024-04-12 16:06:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060634770002TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770019TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770040TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770064TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770071TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770095TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770101TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770118TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770279TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-01-24
05060634770323TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-01-24
05060634770354TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770729TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770736TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770743TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770750TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770767TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770774TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770781TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770927TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770934TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770941TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770958TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770972TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770989TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770996TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634771047TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770361TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-02-19
18052469477199OSCAR PROORTHOFIX SRL12023-04-28
18052469477205OSCAR PROORTHOFIX SRL12023-04-28
18052469477212OSCAR PROORTHOFIX SRL12023-04-28
03609820578569SATELECSATELECPIEZOTOME SOLO M+ US2022-07-13
03609820578033ACTEONSATELECCMF KIT NON-STERIL2022-04-15
03609820876023ACTEONSATELECBS1 XXL M+ TIP N STER2022-04-15
03609820876047ACTEONSATELECBS6 XXL M+ TIP N STER2022-04-15
03609820876054ACTEONSATELECBS2L XL M+ TIP N STER2022-04-15
03609820876061ACTEONSATELECBS2R XL M+ TIP N STER2022-04-15
03609820876078ACTEONSATELECLC1 XL M+ TIP N STER2022-04-15
03609820876085ACTEONSATELECBS1 RD M+ TIP N STER2022-04-15
03609820876092ACTEONSATELECDB 2 M+ TIP N STER2022-04-15
03609820876108ACTEONSATELECDB 1 M+ TIP N STER2022-04-15
03609820876115ACTEONSATELECBS1S M+ TIP N STER2022-04-15
03609820876122ACTEONSATELECBS1L M+ TIP N STER2022-04-15
03609820876139ACTEONSATELECBS2L M+ TIP N STER2022-04-15
03609820876146ACTEONSATELECBS2R M+ TIP N STER2022-04-15
03609820876153ACTEONSATELECBS4 M+ TIP N STER2022-04-15
03609820876160ACTEONSATELECBS5 M+ TIP N STER2022-04-15
03609820876177ACTEONSATELECBS6 M+ TIP N STER2022-04-15
03609820876184ACTEONSATELECSL1 M+ TIP N STER2022-04-15
03609820876191ACTEONSATELECSL2 M+ TIP N STER2022-04-15
03609820876207ACTEONSATELECSL3 M+ TIP N STER2022-04-15
03609820876214ACTEONSATELECSL4 M+ TIP N STER2022-04-15
03609820876221ACTEONSATELECSL5 M+ TIP N STER2022-04-15
03609820876238ACTEONSATELECLC1 M+ TIP N STER2022-04-15
03609820876252ACTEONSATELECLC2 M+ TIP N STER2022-04-15
03609820876269ACTEONSATELECLC2L M+ TIP N STER2022-04-15
03609820876276ACTEONSATELECLC2R M+ TIP N STER2022-04-15
03609820876283ACTEONSATELECNINJA M+ TIP N STER2022-04-15
03609820876290ACTEONSATELECCS1 M+ TIP N STER2022-04-15
03609820876306ACTEONSATELECCS2 M+ TIP N STER2022-04-15
03609820876313ACTEONSATELECCS3 M+ TIP N STER2022-04-15
03609820876320ACTEONSATELECCS4 M+ TIP N STER2022-04-15
03609820876337ACTEONSATELECCS5 M+ TIP N STER2022-04-15
03609820876344ACTEONSATELECCS6 M+ TIP N STER2022-04-15
03609820876412ACTEONSATELECTKW1 II TIP N STER2022-04-15
03609820876429ACTEONSATELECTKW2 II TIP N STER2022-04-15
03609820876436ACTEONSATELECTKW3 II TIP N STER2022-04-15
03609820876443ACTEONSATELECTKW4 II TIP N STER2022-04-15
03609820876450ACTEONSATELECTKW5 II TIP N STER2022-04-15
03609820876511ACTEONSATELECCE1 II TIP N STER2022-04-15
03609820876528ACTEONSATELECCE2 II TIP N STER2022-04-15
03609820876535ACTEONSATELECCE3 II TIP N STER2022-04-15
03609820876801ACTEONSATELECRHS6 M+ N STER TIP2022-04-15
03609820876818ACTEONSATELECRHS BASIC M+ N STER KIT2022-04-15
03609820876894ACTEONSATELECRHS EXPERT M+ N STER KIT2022-04-15
03609820876771ACTEONSATELECRHS3L M+ N STER TIP2022-04-14
03609820876788ACTEONSATELECRHS3R M+ N STER TIP2022-04-14
03609820876795ACTEONSATELECRHS5 M+ N STER TIP2022-04-14
03609820876825ACTEONSATELECRHS4R M+ N STER TIP2022-04-14
03609820876832ACTEONSATELECRHS4L M+ N STER TIP2022-04-14
03609820876863ACTEONSATELECRHS2Hb M+ N STER TIP2022-04-14