TRIMEDYNE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14199511419951TRIMEDYNE, INC.1N2026-01-01519 N. Smith Avenue, Suite 105 Corona CA US 92878

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M4731210VHP0Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System - Model 1210-VHP - OmniPulse Max Holmium Laser System8007335273customerservice@trimedyne.com
M47320462HP0Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle - SwitchTip, Sidefire, 25cm8007335273customerservice@trimedyne.com
M47320474HP0Trimedyne® OmniTip™ Switchable Tip - Straight - Tip, Switchable, Omni HP System, 0 degree8007335273customerservice@trimedyne.com
M47320475HP0Trimedyne® OmniTip™ Switchable Tip - 20° - Tip, Switchable, Omni HP System, 20 degree8007335273customerservice@trimedyne.com
M47320475MHP0Trimedyne® Reposable OmniTip™ Switchable Tip - 20° - Multiuse Switchable Tip, Omni HP System, 20 degree8007335273customerservice@trimedyne.com
M47320476HP0Trimedyne® OmniTip™ Switchable Tip - 30° - Tip, Switchable, Omni HP System, 30 degree8007335273customerservice@trimedyne.com
M47320476MHP0Trimedyne® Reposable OmniTip™ Switchable Tip - 30° - Multiuse Switchable Tip, Omni HP System, 30 degree8007335273customerservice@trimedyne.com
M47321200Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System - Model 2120 - OmniPulse Mini Holmium Laser System8007335273customerservice@trimedyne.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
690771812998041K992574OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500AGEX1999-10-29
690771621595699K992230OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HPGEX1999-07-12
690771954138272K973172RESPOSABLE BARE FIBERSGEX1998-02-03
690772032236119K962632OMNIPULSE/OMNIPULSE-MAXGEX1997-01-16
690771798168435K951562OMNIPULSE-MAX HOLMIUM LASERGEX1995-07-21
690771187395761K941419DISPOSABLE SPINAL INTRODUCER SHEATHGEX1994-06-21
690771508188526K934865OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEMGEX1994-05-12
690771154369056K925124TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYSTGEX1994-03-01
690771099889029K923191SWITCHABLE TIP SYSTEMGEX1993-03-31
690771741221959K922496TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTGEX1994-03-01
690771344188091K915117MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEMGEX1992-04-02
690771620049885K914952MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEMGEX1991-12-20
690771023843925K911457TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTGEX1991-09-05
690772037273832K903154CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBERGEX1990-11-23
690771708704828K053457VAPORMAX IIGEX2005-12-21
690771752191465K043012OMNIPULSE MINI, MODEL 2120GEX2004-11-17
690771481641641K041660TRIMEDYNE HOLMIUM LASER SYSTEMSGEX2004-09-08
690771520605047K022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHGEX2002-11-07
690771765028451K013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-AGEX2002-09-23
690771035978327K002308OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-AGEX2000-12-20
690771829747997K001676OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-AGEX2000-11-02
690771180918219

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX212005-12-21

PMA#

43 records. Showing 1-40. Next

PMN#

57 records. Showing 1-40. Next

GUDID#

87 records. Showing 1-40. Next