FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K021419 |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
AART MALAR IMPLANT |
07/02/2002 |
K971479 |
ALLIED BIOMEDICAL CORP. |
DURALASTIC ANATOMICAL MALAR IMPLANTS |
07/18/1997 |
K960362 |
CERAMED CORP. |
PERMAMESH HYDROXYLAPATITE MATRIX |
03/20/1996 |
K960354 |
CERAMED CORP. |
PERMAMESH-D HYDROXYLAPATITE MATRIX |
03/20/1996 |
K973574 |
HANSON MEDICAL, INC. |
DURALASTIC ANATOMICAL MALAR IMPLANT |
10/24/1997 |
K002886 |
IMPLANTECH ASSOCIATES, INC. |
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) |
11/24/2000 |
K973502 |
IMPLANTECH ASSOCIATES, INC. |
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT |
11/07/1997 |
K962261 |
IMPLANTECH ASSOCIATES, INC. |
IMPLANTECH WM NASAL-LABIAL IMPLANT |
08/19/1996 |
K961511 |
LIFECORE BIOMEDICAL, INC. |
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER |
06/28/1996 |
K970400 |
ORTHOFIX, INC. |
BONE SOURCE HYDROXYAPATITE |
05/02/1997 |
K992240 |
PILLAR SURGICAL, INC. |
PILLAR MALAR IMPLANT |
11/22/1999 |
K961080 |
RAND SCIENTIFIC CORP. |
MEDIAL MALAR IMPLANT |
04/19/1996 |
K982763 |
SEARE BIOMEDICAL CORP. |
SEARE BIOMEDICAL MALAR IMPLANTS |
09/30/1998 |
K981835 |
SILIMED, LLC. |
SILIMED MALAR IMPLANT |
07/09/1998 |
K980140 |
SPECTRUM DESIGNS, INC. |
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT |
03/03/1998 |
K980139 |
SPECTRUM DESIGNS, INC. |
SPECTRUM DESIGNS PROFILE MALAR IMPLANT |
03/03/1998 |
K980141 |
SPECTRUM DESIGNS, INC. |
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT |
03/03/1998 |
K964443 |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
SURGIFORM ANATOMICAL MALAR |
12/20/1996 |
K983756 |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
SURGIFORM ANATOMICAL MALAR |
11/20/1998 |
K961210 |
W.L. GORE & ASSOCIATES,INC |
SAM FACIAL IMPLANT |
06/19/1996 |