FDA 510(k) Applications for Medical Device Product Code "FZE"
(Prosthesis, Nose, Internal)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K021418 |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
AART NASAL IMPLANT |
07/02/2002 |
K971481 |
ALLIED BIOMEDICAL CORP. |
DURALASTIC ANATOMICAL NASAL IMPLANTS |
07/18/1997 |
K973573 |
HANSON MEDICAL, INC. |
DURALASTIC ANATOMICAL NASAL IMPLANTS |
11/13/1997 |
K090803 |
HANSON MEDICAL, INC. |
HANSON MEDICAL FACIAL IMPLANTS |
06/30/2010 |
K041690 |
HANSON MEDICAL, INC. |
MONARCH NASAL IMPLANT |
02/11/2005 |
K071018 |
HANSON MEDICAL, INC. |
MONARCH NASAL IMPLANT |
05/25/2007 |
K962824 |
IMPLANTECH ASSOCIATES, INC. |
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT |
10/03/1996 |
K090630 |
NOBEL BIOCARE AB |
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) |
06/02/2009 |
K992242 |
PILLAR SURGICAL, INC. |
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS |
11/22/1999 |
K961124 |
RAND SCIENTIFIC CORP. |
THE NAUTILUS |
04/19/1996 |
K982753 |
SEARE BIOMEDICAL CORP. |
SEARE BIOMEDICAL NASAL IMPLANTS |
09/30/1998 |
K981833 |
SILIMED, LLC. |
SILIMED NASAL L SHAPED IMPLANT |
06/26/1998 |
K161548 |
SOUTHERN IMPLANTS (PTY) LTD. |
Osseointegrated Fixtures |
12/01/2016 |
K983755 |
SURGICAL TECHNOLOGY LABORATORIES, INC. |
NASAL DORSAL SERIES |
11/20/1998 |
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