Trimedyne, Inc.

FDA 510(k) & PMA Approved Devices — 58 products

Total Devices58

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K053457	VAPORMAX II	GEX	2005-12-21	View
510(k)	K050412	VAPORMAX	GEX	2005-03-14	View
510(k)	K043012	OMNIPULSE MINI, MODEL 2120	GEX	2004-11-17	View
510(k)	K041660	TRIMEDYNE HOLMIUM LASER SYSTEMS	GEX	2004-09-08	View
510(k)	K022655	TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH	GEX	2002-11-07	View
510(k)	K013974	RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A	GEX	2002-09-23	View
510(k)	K002308	OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A	GEX	2000-12-20	View
510(k)	K001676	OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A	GEX	2000-11-02	View
510(k)	K992574	OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A	GEX	1999-10-29	View
510(k)	K992230	OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP	GEX	1999-07-12	View
510(k)	K973172	RESPOSABLE BARE FIBERS	GEX	1998-02-03	View
510(k)	K970422	RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS	GEX	1997-04-21	View
510(k)	K964585	RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)	GEX	1997-04-17	View
510(k)	K962632	OMNIPULSE/OMNIPULSE-MAX	GEX	1997-01-16	View
510(k)	K954597	RIGHT ANGLE LASER FIBERS	GEX	1996-03-11	View
510(k)	K953494	TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY	GEX	1995-09-14	View
510(k)	K951562	OMNIPULSE-MAX HOLMIUM LASER	GEX	1995-07-21	View
510(k)	K944204	LATERALASE, MODIFIED	GEX	1994-11-28	View
510(k)	K941419	DISPOSABLE SPINAL INTRODUCER SHEATH	GEX	1994-06-21	View
510(k)	K932883	OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM	GEX	1994-06-21	View