FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K083780 |
AUDIO TECHNOLOGIES S.R.L. |
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 |
03/23/2009 |
K963899 |
EXMOOR PLASTICS LTD. |
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) |
08/22/1997 |
K981088 |
EXMOOR PLASTICS LTD. |
MILLS COLUMELLA PROSTHESIS |
06/05/1998 |
K091187 |
Grace Medical, Inc. |
GRACE DYNAMIC TORP |
09/14/2009 |
K990601 |
GYRUS ENT L.L.C. |
BOJRAB MICRO-TORP, MODEL 7014-5845 |
03/31/1999 |
K001902 |
GYRUS ENT L.L.C. |
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD |
07/10/2000 |
K002378 |
GYRUS ENT L.L.C. |
MODULAR PORP AND TORP MODEL TBD |
08/29/2000 |
K972585 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN |
08/04/1997 |
K042503 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM |
10/01/2004 |
K030492 |
INVOTEC INTERNATIONAL, INC. |
TITANIUM OSSICULAR REPLACMENT SYSTEM |
03/03/2003 |
K043375 |
KARL STORZ ENDOSCOPY |
FISCH TITANIUM MIDDLE EAR PROSTHESES |
01/24/2005 |
K001404 |
MEDNET LOCATOR, INC. |
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON |
08/08/2000 |
K001406 |
MEDNET LOCATOR, INC. |
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES |
08/08/2000 |
K972735 |
MEDNET LOCATOR, INC. |
TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) |
09/05/1997 |
K992138 |
MICROMEDICS, INC. |
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES |
08/09/1999 |
K993583 |
STRYKER CORP. |
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM |
11/10/1999 |