FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K964798 |
ANTHONY D. PRESCOTT |
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
01/02/1997 |
K001142 |
AUDIO TECHNOLOGIES S.R.L. |
AUDIO TECHNOLOGIES S:R.1 |
06/23/2000 |
K981045 |
EXMOOR PLASTICS LTD. |
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS |
05/20/1998 |
K974365 |
EXMOOR PLASTICS LTD. |
MILLS INCUS HA SLEEVE |
01/22/1998 |
K061853 |
Grace Medical, Inc. |
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES |
08/18/2006 |
K080070 |
Grace Medical, Inc. |
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
04/17/2008 |
K063374 |
Grace Medical, Inc. |
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE |
12/06/2006 |
K963752 |
Grace Medical, Inc. |
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS |
10/10/1996 |
K060518 |
Grace Medical, Inc. |
PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
06/28/2006 |
K972815 |
Grace Medical, Inc. |
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT |
10/08/1997 |
K991394 |
Grace Medical, Inc. |
STAPES PROSTHESES |
05/18/1999 |
K000256 |
GYRUS ENT L.L.C. |
CAP PORP, CAP TORP |
02/11/2000 |
K962564 |
GYRUS ENT L.L.C. |
RICHARDS TOTAL/PARTIAL PROSTHESIS |
01/22/1997 |
K033554 |
GYRUS ENT L.L.C. |
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS |
11/24/2003 |
K002464 |
GYRUS ENT L.L.C. |
SMITH & NEPHEW OFF-CENTERED PORP |
08/29/2000 |
K003214 |
GYRUS ENT L.L.C. |
SMITH & NEPHEW PISTONS |
10/31/2000 |
K002737 |
GYRUS ENT L.L.C. |
SMITH & NEPHEW PORPS & TORPS |
10/12/2000 |
K000858 |
GYRUS ENT L.L.C. |
WEHRS INCUS-STAPES |
04/03/2000 |
K972492 |
HEINZ KURZ |
BELL PROSTHESIS (PARTIAL) |
08/04/1997 |
K973356 |
HEINZ KURZ |
K-PISTON WITH BAND HOOK /ANGULAR PISTON |
11/21/1997 |
K010442 |
HEINZ KURZ |
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 |
03/08/2001 |
K990923 |
HEINZ KURZ |
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 |
03/31/1999 |
K013573 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 |
11/09/2001 |
K021479 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 |
05/21/2002 |
K002221 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 |
08/09/2000 |
K112616 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS |
02/08/2013 |
K130512 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS |
12/02/2013 |
K992839 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE |
09/16/1999 |
K972737 |
MEDNET LOCATOR, INC. |
CAUSSE PISTON |
09/05/1997 |
K972734 |
MEDNET LOCATOR, INC. |
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) |
09/05/1997 |
K945105 |
MICROMED DEVELOPMENT CORP. |
POLY/PLATINUM WIRE PISTON |
05/14/1996 |
K993234 |
MICROMEDICS, INC. |
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
11/10/1999 |
K964909 |
XOMED, INC. |
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS |
03/10/1997 |
K002897 |
XOMED, INC. |
TITANIUM MIDDLE EAR PROSTHESES |
10/11/2000 |