FDA.reportPublic FDA data

Hard/soft-tissue ultrasonic surgical system

Definition
An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement 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
241
Last updated
2026-10-15 14:54:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbH305020242025-07-08
03609820128184ACTEONSATELEC05.001.4012025-01-17
03609820877334ACTEONSATELEC03.000.424S2025-01-17
05060634770378TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-04-04
05060634770552TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-13
05060634771092TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-13
05060634771122TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-13
05060634771139TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-13
05060634771146TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-13
05060634771153TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-13
05060634771160TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-15
05060634771177TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-15
05060634771351TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-15
05060634771368TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-15
05060634771375TORSRADLEY SCIENTIFIC LIMITEDSeries 12024-11-15
05060634771771TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771788TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771795TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771801TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771818TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771825TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771832TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771849TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771856TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771863TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771870TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771887TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771894TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771900TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771917TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634771924TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634772006TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
05060634772013TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-11-19
08404535024227Axiom BladesPeter Brasseler Holdings, LLCBRAXM-GP82026-04-29
08404535024258Axiom BladesPeter Brasseler Holdings, LLCBRAXM-FP14M2026-04-29
08404535024289Axiom BladesPeter Brasseler Holdings, LLCBRAXM-FC62026-04-29
08404535024319Axiom BladesPeter Brasseler Holdings, LLCBRAXM-FP8S2026-04-29
08404535024340Axiom BladesPeter Brasseler Holdings, LLCBRAXM-HP8S2026-04-29
08404535024371Axiom BladesPeter Brasseler Holdings, LLCBRAXM-HP8M2026-04-29
08404535024401Axiom BladesPeter Brasseler Holdings, LLCBRAXM-FP8M2026-04-29
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbH305000002025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbH305010002025-07-08
10886982351579NASynthes GmbHSD399.1902026-02-11
05060634771931TORSRADLEY SCIENTIFIC LIMITEDSeries 12026-02-03
05060634771948TORSRADLEY SCIENTIFIC LIMITEDSeries 12026-02-03
05060634771955TORSRADLEY SCIENTIFIC LIMITEDSeries 12026-02-03
03609820876948ACTEONSATELECRHL22025-12-12
08404535022452Axiom BladesPeter Brasseler Holdings, LLCBRAXM-SS6PR2025-12-10
08404535022483Axiom BladesPeter Brasseler Holdings, LLCBRAXM-FS6PR2025-12-10
08404535022506Axiom BladesPeter Brasseler Holdings, LLCBRAXM-D3PR2025-12-10
08404535022568Axiom BladesPeter Brasseler Holdings, LLCBRAXM-HS5PR2025-12-10
08404535022599Axiom BladesPeter Brasseler Holdings, LLCBRAXM-EXTSXL2025-12-10
08404535022629Axiom BladesPeter Brasseler Holdings, LLCBRAXM-RS62025-12-10
08404535022650Axiom BladesPeter Brasseler Holdings, LLCBRAXM-EXTXL2025-12-10
08404535022681Axiom BladesPeter Brasseler Holdings, LLCBRAXM-FS6PRXL2025-12-10
05060634772020TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-12-09
05060634772037TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-12-09
05060634772044TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-12-09
05060634772051TORSRADLEY SCIENTIFIC LIMITEDSeries 12025-12-09
06972603515868SMTPSMTP Medical Co., Ltd.XDF028015212025-09-24
06972603515875SMTPSMTP Medical Co., Ltd.XDF028015212025-09-24
06972603515882SMTPSMTP Medical Co., Ltd.XDF028015212025-09-24
06972603515899SMTPSMTP Medical Co., Ltd.XDF028015212025-09-24
06972603515905SMTPSMTP Medical Co., Ltd.XDF02806510C2025-09-24
06972603515912SMTPSMTP Medical Co., Ltd.XDF02806510C2025-09-24
06972603515929SMTPSMTP Medical Co., Ltd.XDF028065252025-09-24
06972603515936SMTPSMTP Medical Co., Ltd.XDF028065252025-09-24
06972603515943SMTPSMTP Medical Co., Ltd.XDF028065232025-09-24
06972603515950SMTPSMTP Medical Co., Ltd.XDF028065232025-09-24
06972603515967SMTPSMTP Medical Co., Ltd.XDF028125322025-09-24
06972603515974SMTPSMTP Medical Co., Ltd.XDF028125322025-09-24
06972603515981SMTPSMTP Medical Co., Ltd.XDF028065522025-09-24
06972603515998SMTPSMTP Medical Co., Ltd.XDF028065182025-09-24
06972603516001SMTPSMTP Medical Co., Ltd.XDF028065182025-09-24
06972603516018SMTPSMTP Medical Co., Ltd.XDF028125332025-09-24
06972603519491SMTPSMTP Medical Co., Ltd.XDF027015112025-09-24
06972603519507SMTPSMTP Medical Co., Ltd.XDF027125602025-09-24
06972603519514SMTPSMTP Medical Co., Ltd.XDF027125602025-09-24
06972603519521SMTPSMTP Medical Co., Ltd.XDF027125632025-09-24
06972603519538SMTPSMTP Medical Co., Ltd.XDF027125632025-09-24