Company ยท US
Trimedyne, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2005. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2005 | K053457 | VAPORMAX II Trimedyne, Inc. | GEX |
| Mar 14, 2005 | K050412 | VAPORMAX Trimedyne, Inc. | GEX |
| Nov 17, 2004 | K043012 | OMNIPULSE MINI, MODEL 2120 Trimedyne, Inc. | GEX |
| Sep 8, 2004 | K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS Trimedyne, Inc. | GEX |
| Nov 7, 2002 | K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH Trimedyne, Inc. | GEX |
| Sep 23, 2002 | K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A Trimedyne, Inc. | GEX |
| Dec 20, 2000 | K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A Trimedyne, Inc. | GEX |
| Nov 2, 2000 | K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A Trimedyne, Inc. | GEX |
| Oct 29, 1999 | K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A Trimedyne, Inc. | GEX |
| Jul 12, 1999 | K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP Trimedyne, Inc. | GEX |
| Feb 3, 1998 | K973172 | RESPOSABLE BARE FIBERS Trimedyne, Inc. | GEX |
| Apr 21, 1997 | K970422 | RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS Trimedyne, Inc. | GEX |
| Apr 17, 1997 | K964585 | RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) Trimedyne, Inc. | GEX |
| Jan 16, 1997 | K962632 | OMNIPULSE/OMNIPULSE-MAX Trimedyne, Inc. | GEX |
| Mar 11, 1996 | K954597 | RIGHT ANGLE LASER FIBERS Trimedyne, Inc. | GEX |
| Sep 14, 1995 | K953494 | TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY Trimedyne, Inc. | GEX |
| Jul 21, 1995 | K951562 | OMNIPULSE-MAX HOLMIUM LASER Trimedyne, Inc. | GEX |
| Nov 28, 1994 | K944204 | LATERALASE, MODIFIED Trimedyne, Inc. | GEX |
| Jun 21, 1994 | K941419 | DISPOSABLE SPINAL INTRODUCER SHEATH Trimedyne, Inc. | GEX |
| Jun 21, 1994 | K932883 | OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM Trimedyne, Inc. | GEX |
| May 12, 1994 | K934865 | OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM Trimedyne, Inc. | GEX |
| Mar 1, 1994 | K925414 | LATERALASE CATHETER Trimedyne, Inc. | GEX |
| Mar 1, 1994 | K925124 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST Trimedyne, Inc. | GEX |
| Mar 1, 1994 | K922497 | OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM Trimedyne, Inc. | GEX |
| Mar 1, 1994 | K922496 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST Trimedyne, Inc. | GEX |
| Mar 31, 1993 | K923191 | SWITCHABLE TIP SYSTEM Trimedyne, Inc. | GEX |
| Mar 20, 1993 | K922213 | LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK Trimedyne, Inc. | GEX |
| Apr 29, 1992 | K920934 | HALOCATH LASER CATHETERS Trimedyne, Inc. | GEX |
| Apr 2, 1992 | K920632 | SIDE FIRING FIBERS Trimedyne, Inc. | GEX |
| Apr 2, 1992 | K920625 | LATERALASE Trimedyne, Inc. | GEX |
| Apr 2, 1992 | K915117 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM Trimedyne, Inc. | GEX |
| Feb 24, 1992 | K915354 | LATERALASE Trimedyne, Inc. | GEX |
| Jan 23, 1992 | K915223 | METAL ENCLOSED SIDE FIRING FIBERS Trimedyne, Inc. | GEX |
| Dec 20, 1991 | K914952 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM Trimedyne, Inc. | GEX |
| Oct 8, 1991 | K913109 | LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK Trimedyne, Inc. | GEX |
| Sep 5, 1991 | K911457 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST Trimedyne, Inc. | GEX |
| Jun 24, 1991 | K903418 | LATERALASE TM Trimedyne, Inc. | GEX |
| Mar 28, 1991 | K905708 | TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM Trimedyne, Inc. | GEX |
| Mar 5, 1991 | K903838 | OPTILASE (TM) MODEL 900 ARGON Trimedyne, Inc. | GEX |
| Nov 23, 1990 | K903154 | CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER Trimedyne, Inc. | GEX |
| Oct 3, 1990 | K902940 | CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM Trimedyne, Inc. | GEX |
| Oct 3, 1990 | K902939 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM Trimedyne, Inc. | GEX |
| Jul 23, 1990 | K902263 | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION Trimedyne, Inc. | GGX |
| Apr 26, 1990 | K895538 | ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY Trimedyne, Inc. | LYK |
| Feb 22, 1990 | K897157 | OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM Trimedyne, Inc. | GEX |
| Jan 3, 1990 | K895874 | OPTILASE YAG MODEL 1000 Trimedyne, Inc. | GEX |
| Jan 3, 1990 | K895774 | GYN-PROBE Trimedyne, Inc. | GEX |
| Oct 10, 1989 | K894977 | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM Trimedyne, Inc. | GEX |
| Feb 7, 1989 | K890279 | MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER Trimedyne, Inc. | GEX |
| Aug 7, 1987 | K870505 | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL Trimedyne, Inc. | LLO |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||