FDA 510(k) Applications Submitted by BIOMEDICAL ENT., INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K131640 |
06/04/2013 |
SMOOTH OR THREADED METALLIC BONE FASTENER |
BIOMEDICAL ENT., INC. |
K133780 |
12/12/2013 |
SPEED XL |
BIOMEDICAL ENT., INC. |
K133844 |
12/18/2013 |
SPEED TRIAD |
BIOMEDICAL ENT., INC. |
K091951 |
07/01/2009 |
HAMMERLOCK |
BIOMEDICAL ENT., INC. |
K102107 |
07/27/2010 |
OSSTAPLE CHILL |
BIOMEDICAL ENT., INC. |
K001219 |
04/17/2000 |
MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM |
BIOMEDICAL ENT., INC. |
K001353 |
04/28/2000 |
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM |
BIOMEDICAL ENT., INC. |
K001354 |
04/28/2000 |
MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM |
BIOMEDICAL ENT., INC. |
K971782 |
05/14/1997 |
BONE AND MARROW COLLECTION SYSTEM KIT |
BIOMEDICAL ENT., INC. |
K961901 |
05/16/1996 |
BONE & MARROW COLLECTION SYSTEM |
BIOMEDICAL ENT., INC. |
K023203 |
09/25/2002 |
OSSTAPLE |
BIOMEDICAL ENT., INC. |
K964073 |
10/11/1996 |
BME BONE DRILL BITS |
BIOMEDICAL ENT., INC. |
K993714 |
11/02/1999 |
MEMOGRAPH STAPLE, WARM SYSTEM |
BIOMEDICAL ENT., INC. |
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