Medical Device Manufacturer · US , Walker , MI

Trimedyne, Inc. - FDA 510(k) Cleared Devices

58 submissions · 58 cleared · Since 1981
58
Total
58
Cleared
0
Denied
58 devices
26-50 of 58
Cleared Mar 31, 1993
SWITCHABLE TIP SYSTEM
K923191 · GEX
General & Plastic Surgery · 274d
Cleared Mar 20, 1993
LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK
K922213 · GEX
General & Plastic Surgery · 312d
Cleared Apr 29, 1992
HALOCATH LASER CATHETERS
K920934 · GEX
General & Plastic Surgery · 61d
Cleared Apr 02, 1992
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K915117 · GEX
General & Plastic Surgery · 141d
Cleared Apr 02, 1992
LATERALASE
K920625 · GEX
General & Plastic Surgery · 50d
Cleared Apr 02, 1992
SIDE FIRING FIBERS
K920632 · GEX
General & Plastic Surgery · 50d
Cleared Feb 24, 1992
LATERALASE
K915354 · GEX
General & Plastic Surgery · 90d
Cleared Jan 23, 1992
METAL ENCLOSED SIDE FIRING FIBERS
K915223 · GEX
General & Plastic Surgery · 64d
Cleared Dec 20, 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K914952 · GEX
General & Plastic Surgery · 45d
Cleared Oct 08, 1991
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK
K913109 · GEX
General & Plastic Surgery · 88d
Cleared Sep 05, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST
K911457 · GEX
General & Plastic Surgery · 155d
Cleared Jun 24, 1991
LATERALASE TM
K903418 · GEX
General & Plastic Surgery · 328d
Cleared Mar 28, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM
K905708 · GEX
General & Plastic Surgery · 97d
Cleared Mar 05, 1991
OPTILASE (TM) MODEL 900 ARGON
K903838 · GEX
General & Plastic Surgery · 196d
Cleared Nov 23, 1990
CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER
K903154 · GEX
General & Plastic Surgery · 128d
Cleared Oct 03, 1990
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K902939 · GEX
General & Plastic Surgery · 92d
Cleared Oct 03, 1990
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
K902940 · GEX
General & Plastic Surgery · 92d
Cleared Jul 23, 1990
OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
K902263 · GGX
Hematology · 63d
Cleared Apr 26, 1990
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · LYK
Cardiovascular · 225d
Cleared Feb 22, 1990
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
K897157 · GEX
General & Plastic Surgery · 58d
Cleared Jan 03, 1990
GYN-PROBE
K895774 · GEX
General & Plastic Surgery · 99d
Cleared Jan 03, 1990
OPTILASE YAG MODEL 1000
K895874 · GEX
General & Plastic Surgery · 91d
Cleared Oct 10, 1989
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K894977 · GEX
General & Plastic Surgery · 64d
Cleared Feb 07, 1989
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER
K890279 · GEX
General & Plastic Surgery · 26d
Cleared Aug 07, 1987
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
K870505 · LLO
Anesthesiology · 184d
Filters