Gyrus Ent LLC - FDA 510(k) Cleared Devices
Recent clearances: RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM, DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE, HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gyrus Ent LLC Ear, Nose, Throat ✕
21 devices
Cleared
Aug 20, 2004
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION...
Ear, Nose, Throat
126d
Cleared
Mar 03, 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
Ear, Nose, Throat
70d
Cleared
Nov 24, 2003
SMART OFFSET STAPES PISTON
Ear, Nose, Throat
12d
Cleared
Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
Ear, Nose, Throat
162d
Cleared
Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
Ear, Nose, Throat
14d
Cleared
Oct 31, 2000
SMITH & NEPHEW PISTONS
Ear, Nose, Throat
18d
Cleared
Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
Ear, Nose, Throat
41d
Cleared
Aug 29, 2000
MODULAR PORP AND TORP MODEL TBD
Ear, Nose, Throat
25d
Cleared
Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
Ear, Nose, Throat
19d
Cleared
Jul 10, 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
Ear, Nose, Throat
18d
Cleared
Jun 19, 2000
PC COATED FLUOROPLASTIC VENT TUBES
Ear, Nose, Throat
98d
Cleared
Apr 03, 2000
WEHRS INCUS-STAPES
Ear, Nose, Throat
18d
Cleared
Feb 11, 2000
CAP PORP, CAP TORP
Ear, Nose, Throat
14d
Cleared
Nov 23, 1999
TURBO 7000 SHAVER AND DRILL CONSOLE
Ear, Nose, Throat
77d
Cleared
Aug 26, 1999
FLUOROPLASTIC VENTILATION TUBES
Ear, Nose, Throat
56d
Cleared
Mar 31, 1999
BOJRAB MICRO-TORP, MODEL 7014-5845
Ear, Nose, Throat
35d
Cleared
Feb 02, 1999
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH,...
Ear, Nose, Throat
11d
Cleared
Mar 04, 1998
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
Ear, Nose, Throat
107d
Cleared
Jan 12, 1998
ESSENTIAL SHAVER SYSTEM
Ear, Nose, Throat
61d
Cleared
Sep 29, 1997
ENT IRRIGATING PUMP (70327700)
Ear, Nose, Throat
27d
Cleared
Jan 22, 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
Ear, Nose, Throat
205d