FDA 510(k) Applications Submitted by Jeff Cobb
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080070 |
01/10/2008 |
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
| K990213 |
01/22/1999 |
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET |
GYRUS ENT L.L.C. |
| K060518 |
02/27/2006 |
PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
| K091107 |
04/16/2009 |
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM |
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC |
| K091187 |
04/23/2009 |
GRACE DYNAMIC TORP |
Grace Medical, Inc. |
| K061853 |
06/30/2006 |
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
| K062385 |
08/15/2006 |
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES |
Grace Medical, Inc. |
| K992994 |
09/07/1999 |
TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; |
GYRUS ENT L.L.C. |
| K062672 |
09/08/2006 |
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES |
Grace Medical, Inc. |
| K954696 |
10/12/1995 |
ROGOZINSKI THORACOLUMBAR SPINAL ROD |
SMITH & NEPHEW RICHARDS, INC. |
| K183009 |
10/31/2018 |
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES |
Hemostatix Medical Technologies, LLC |
| K063374 |
11/08/2006 |
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE |
Grace Medical, Inc. |
| K053333 |
12/01/2005 |
EAGLEVISION GELLANSERTS, MODEL REF 0040 |
EAGLE VISION, INC. |
| K020778 |
03/11/2002 |
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 |
GYRUS ENT L.L.C. |
| K020067 |
01/09/2002 |
GYRUS ENT SOMNOPLASTY GENERATOR |
GYRUS ENT L.L.C. |
| K021777 |
05/30/2002 |
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
GYRUS ENT L.L.C. |
| K003214 |
10/13/2000 |
SMITH & NEPHEW PISTONS |
GYRUS ENT L.L.C. |
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