Trimedyne, Inc. - FDA 510(k) Cleared Devices
58
Total
58
Cleared
0
Denied
48 devices
Cleared
Mar 31, 1993
SWITCHABLE TIP SYSTEM
General & Plastic Surgery
274d
Cleared
Mar 20, 1993
LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK
General & Plastic Surgery
312d
Cleared
Apr 29, 1992
HALOCATH LASER CATHETERS
General & Plastic Surgery
61d
Cleared
Apr 02, 1992
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
General & Plastic Surgery
141d
Cleared
Apr 02, 1992
LATERALASE
General & Plastic Surgery
50d
Cleared
Apr 02, 1992
SIDE FIRING FIBERS
General & Plastic Surgery
50d
Cleared
Feb 24, 1992
LATERALASE
General & Plastic Surgery
90d
Cleared
Jan 23, 1992
METAL ENCLOSED SIDE FIRING FIBERS
General & Plastic Surgery
64d
Cleared
Dec 20, 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
General & Plastic Surgery
45d
Cleared
Oct 08, 1991
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK
General & Plastic Surgery
88d
Cleared
Sep 05, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST
General & Plastic Surgery
155d
Cleared
Jun 24, 1991
LATERALASE TM
General & Plastic Surgery
328d
Cleared
Mar 28, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM
General & Plastic Surgery
97d
Cleared
Mar 05, 1991
OPTILASE (TM) MODEL 900 ARGON
General & Plastic Surgery
196d
Cleared
Nov 23, 1990
CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER
General & Plastic Surgery
128d
Cleared
Oct 03, 1990
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
General & Plastic Surgery
92d
Cleared
Oct 03, 1990
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
General & Plastic Surgery
92d
Cleared
Feb 22, 1990
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
General & Plastic Surgery
58d
Cleared
Jan 03, 1990
GYN-PROBE
General & Plastic Surgery
99d
Cleared
Jan 03, 1990
OPTILASE YAG MODEL 1000
General & Plastic Surgery
91d
Cleared
Oct 10, 1989
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
General & Plastic Surgery
64d
Cleared
Feb 07, 1989
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER
General & Plastic Surgery
26d
Cleared
Oct 07, 1985
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700
General & Plastic Surgery
181d