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Trimedyne, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
58
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K053457VAPORMAX IIDecember 21, 2005
K050412VAPORMAXMarch 14, 2005
K043012OMNIPULSE MINI, MODEL 2120November 17, 2004
K041660TRIMEDYNE HOLMIUM LASER SYSTEMSSeptember 8, 2004
K022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHNovember 7, 2002
K013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-ASeptember 23, 2002
K002308OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1December 20, 2000
K001676OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-ANovember 2, 2000
K992574OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500AOctober 29, 1999
K992230OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HPJuly 12, 1999
K973172RESPOSABLE BARE FIBERSFebruary 3, 1998
K970422RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMSApril 21, 1997
K964585RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)April 17, 1997
K962632OMNIPULSE/OMNIPULSE-MAXJanuary 16, 1997
K954597RIGHT ANGLE LASER FIBERSMarch 11, 1996
K953494TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE September 14, 1995
K951562OMNIPULSE-MAX HOLMIUM LASERJuly 21, 1995
K944204LATERALASE, MODIFIEDNovember 28, 1994
K941419DISPOSABLE SPINAL INTRODUCER SHEATHJune 21, 1994
K932883OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEMJune 21, 1994