Trimedyne Inc

FDA Filings

This page includes the latest FDA filings for Trimedyne Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USAOTHER OTC MarketTMEDDUNS 057007239
FDA Registration(s)
Registration Number1419951
FEI Number1419951
NameTRIMEDYNE, INC.
Owner & OperatorTRIMEDYNE, INC.
Contact Address530 Technology Drive, Suite 275
Irvine CA 92618 US
Official Correspondent
  • Glenn D Yeik
  • x-949-9513800-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address519 N. Smith Avenue, Suite 105
Corona, CA 92880 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
TRIMEDYNE, INC.
Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System 21202023-06-22
TRIMEDYNE, INC.
100 Watt Holmium Side Fire Fiber SF-6002020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 550 µm Single Use Fiber (SMA Connector) S550SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 550 µm Single Use Holmium Fiber S5502020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector) S365SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber S3652020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 272 µm Single Use Holmium Fiber (SMA Connector) S272SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 272 µm Single Use Holmium Bare Fiber S2722020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 200 µm Single Use Holmium Fiber (SMA Connector) S200SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 200 µm Single Use Holmium Bare Fiber S2002020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 1000 µm Single Use Fiber (SMA Connector) S1000SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 1000 µm Single Use Holmium Fiber S10002020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 365 Series Reusable Fiber (SMA Connector) B365SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 365 Series Reusable Holmium Bare Fiber B3652020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 272 µm Reusable Fiber (SMA Connector) B272SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 272 µm Reusable Holmium Bare Fiber B2722020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 200 µm Reusable Fiber (SMA Connector) B200SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 200 µm Reusable Fiber (SMA Connector), 5m Length B2005M-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber, 5m Length B200-5M2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber B2002020-02-27
TRIMEDYNE, INC.
Trimedyne® 550 µm Test Laser Fiberoptic 7602020-02-27
TRIMEDYNE, INC.
Trimedyne® Omni™ Sterilization Tray System 72052020-02-27
TRIMEDYNE, INC.
Trimedyne® R-50™ Spinal Introduction Cannula 700522020-02-27
TRIMEDYNE, INC.
Trimedyne® Gas-Cooled 600 µm Fiber with Nozzle Tip (SMA Connector) 205032020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight 20497-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Side Firing 20496-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight 20495-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable Tip 20489-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - Side Firing 20479-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - 60° 20478-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® Reposable OmniTip™ Switchable Tip - 30° 20476M-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - 30° 20476-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® Reposable OmniTip™ Switchable Tip - 20° 20475M-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - 20° 20475-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ Switchable Tip - Straight 20474-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Omni™ Multiuse Handpiece With Fiber Assembly (SMA Connector) 20471-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Omni™ Multiuse Handpiece With Fiber Assembly 20470-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle 20462-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® VaporMax® - Ho:YAG Side Firing Fiber-Optic Instrument 20444-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® VaporMAX® - Ho:YAG Side Firing Fiber-Optic Instrument 204442020-02-27
TRIMEDYNE, INC.
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece 20442-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece 204422020-02-27
TRIMEDYNE, INC.
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece 20440-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece 204402020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - Side Firing (SMA Connector) 20409-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - 20° (SMA Connector) 20405-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - 20° 20405-M2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - 60° 20403-M2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - 30° (SMA Connector) 20402-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - 30° 20402-M2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Tapertip™ - Straight 20401-M2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ - 35 cm Side Firing Switchable Tip with Irrigation 20373-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® OmniTip™ - 30 cm Side Firing Switchable Tip with Suction/Irrigation 20371-HP2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Side Firing 29 cm Laser Needle (SMA Connector) 20362-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® Ho:YAG Straightfire™ 25 cm Laser Needle 203022020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 10000 µm Reusable Holmium Bare Fiber (SMA Connector) 20025M-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 1000 µm Reusable Holmium Bare Fiber 20025-M2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber (SMA Connector) 20021M-SMA2020-02-27
TRIMEDYNE, INC.
Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber 20021-M2020-02-27
TRIMEDYNE, INC.
Trimedyne® Model 1500-A Holmium Laser System 1500-A2020-02-27
TRIMEDYNE, INC.
Trimedyne® 1230-30 OmniPulse Jr.™ Holmium Laser System 1230-302020-02-27
TRIMEDYNE, INC.
Trimedyne® 1210-VHPA OmniPulse Max™ Holmium Laser System 1210-VHPA2020-02-27
TRIMEDYNE, INC.
Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System 1210-VHP2020-02-27
TRIMEDYNE, INC.
Trimedyne® 1210 OmniPulse™ Holmium Laser System 12102020-02-27
TRIMEDYNE, INC.
VAPORMAX II2005-12-21
TRIMEDYNE, INC.
VAPORMAX2005-03-14
TRIMEDYNE, INC.
TRIMEDYNE HOLMIUM LASER SYSTEMS2004-09-08
TRIMEDYNE, INC.
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A2002-09-23
TRIMEDYNE, INC.
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A2000-12-20
TRIMEDYNE, INC.
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A2000-11-02
TRIMEDYNE, INC.
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A1999-10-29
TRIMEDYNE, INC.
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP1999-07-12
TRIMEDYNE, INC.
RESPOSABLE BARE FIBERS1998-02-03
TRIMEDYNE, INC.
RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS1997-04-21
TRIMEDYNE, INC.
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)1997-04-17
TRIMEDYNE, INC.
OMNIPULSE/OMNIPULSE-MAX1997-01-16
TRIMEDYNE, INC.
RIGHT ANGLE LASER FIBERS1996-03-11
TRIMEDYNE, INC.
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY1995-09-14
TRIMEDYNE, INC.
OMNIPULSE-MAX HOLMIUM LASER1995-07-21
TRIMEDYNE, INC.
LATERALASE, MODIFIED1994-11-28
TRIMEDYNE, INC.
DISPOSABLE SPINAL INTRODUCER SHEATH1994-06-21
TRIMEDYNE, INC.
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM1994-06-21
TRIMEDYNE, INC.
OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM1994-05-12
TRIMEDYNE, INC.
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER1994-03-17
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1994-03-17
TRIMEDYNE, INC.
LATERALASE CATHETER1994-03-01
TRIMEDYNE, INC.
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST1994-03-01
TRIMEDYNE, INC.
OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM1994-03-01
TRIMEDYNE, INC.
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST1994-03-01
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1994-03-01
TRIMEDYNE, INC.
SWITCHABLE TIP SYSTEM1993-03-31
TRIMEDYNE, INC.
LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK1993-03-20
TRIMEDYNE, INC.
HALOCATH LASER CATHETERS1992-04-29
TRIMEDYNE, INC.
SIDE FIRING FIBERS1992-04-02
TRIMEDYNE, INC.
LATERALASE1992-04-02
TRIMEDYNE, INC.
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM1992-04-02
TRIMEDYNE, INC.
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER1992-03-20
TRIMEDYNE, INC.
LATERALASE1992-02-24
TRIMEDYNE, INC.
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER1992-01-29
TRIMEDYNE, INC.
METAL ENCLOSED SIDE FIRING FIBERS1992-01-23
TRIMEDYNE, INC.
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM1991-12-20
TRIMEDYNE, INC.
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK1991-10-08
TRIMEDYNE, INC.
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST1991-09-05
TRIMEDYNE, INC.
MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM1991-08-20
TRIMEDYNE, INC.
LATERALASE TM1991-06-24
TRIMEDYNE, INC.
TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM1991-03-28
TRIMEDYNE, INC.
OPTILASE (TM) MODEL 900 ARGON1991-03-05
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1991-02-25
TRIMEDYNE, INC.
CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER1990-11-23
TRIMEDYNE, INC.
2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER1990-11-14
TRIMEDYNE, INC.
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM1990-10-03
TRIMEDYNE, INC.
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM1990-10-03
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1990-09-12
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-09-11
TRIMEDYNE, INC.
OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION1990-07-23
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1990-06-25
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-06-25
TRIMEDYNE, INC.
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY1990-04-26
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1990-04-04
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-03-09
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-03-06
TRIMEDYNE, INC.
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM1990-02-22
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-02-09
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-02-01
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1990-01-18
TRIMEDYNE, INC.
OPTILASE YAG MODEL 10001990-01-03
TRIMEDYNE, INC.
GYN-PROBE1990-01-03
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1989-12-13
TRIMEDYNE, INC.
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1989-11-30
TRIMEDYNE, INC.
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM1989-10-10
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1989-09-26
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-08-08
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-07-21
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1989-07-20
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-07-20
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-06-09
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-06-09
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1989-06-06
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-06-06
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-06-06
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-05-01
TRIMEDYNE, INC.
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1989-04-19
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-04-19
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-02-09
TRIMEDYNE, INC.
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER1989-02-07
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1989-01-24
TRIMEDYNE, INC.
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1988-12-15
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1988-10-07
TRIMEDYNE, INC.
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER1988-06-30
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1988-06-14
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1987-11-18
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1987-08-28
TRIMEDYNE, INC.
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL1987-08-07
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1987-07-14
TRIMEDYNE, INC.
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE1987-02-27
TRIMEDYNE, INC.
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE1986-08-07
TRIMEDYNE, INC.
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO1986-07-25
TRIMEDYNE, INC.
HOTIP HEMOSTATIC PROBE1985-11-12
TRIMEDYNE, INC.
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 7001985-10-07
TRIMEDYNE, INC.
A.S.A.P.1984-07-18
TRIMEDYNE, INC.
ENTEROSCOPE1984-06-07
TRIMEDYNE, INC.
ANGIOSCOPE1983-06-02
TRIMEDYNE, INC.
CHEMATIC BICARBONATE DIALYSATE SYSTEM1981-06-16

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