Gyrus Ent LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Gyrus Ent LLC has 28 FDA 510(k) cleared ear, nose, throat devices. Based in Bartlett, US.
Historical record: 28 cleared submissions from 1997 to 2004.
Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gyrus Ent LLC
28 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
Feb 05, 2004
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
General & Plastic Surgery
129d
Cleared
Nov 24, 2003
SMART OFFSET STAPES PISTON
Ear, Nose, Throat
12d
Cleared
May 02, 2003
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING...
Neurology
88d
Cleared
Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
Ear, Nose, Throat
162d
Cleared
Aug 26, 2002
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES...
General & Plastic Surgery
88d
Cleared
May 28, 2002
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
General & Plastic Surgery
78d
Cleared
Apr 04, 2002
GYRUS ENT SOMNOPLASTY GENERATOR
General & Plastic Surgery
85d
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 26, 2000
NEUROTOLOGY DRAPE, MODEL TBD
General Hospital
57d