|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
STRATIFY JCV(TM) ANTIBODY
|
FOCUS DIAGNOSTICS, INC. |
DEN120008 |
K112394 |
01/20/2012 |
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10
|
ETHICON ENDO-SURGERY |
DEN110016 |
K110431 |
04/30/2012 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C
|
PHADIA US INC. |
DEN120001 |
K103039 |
02/15/2012 |
APTIMA TRICHOMONAS VAGINALIS ASSAY
|
GEN-PROBE INCORPORATED |
DEN110012 |
K102911 |
04/19/2011 |
SYMPHONY DEVICE
|
SENSORY MEDICAL, INC |
DEN110011 |
K102873 |
12/18/2013 |
RESTLESS LEG DEVICE
|
MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEE |
DEN110009 |
K102707 |
12/18/2013 |
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL
|
STERIS Corporation |
DEN110006 |
K102469 |
07/12/2013 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR
|
APTUS ENDOSYSTEMS, INC. |
DEN100026 |
K102333 |
11/21/2011 |
WIDEXLINK IN CLEAR SERIES HEARING AIDS
|
OFFICE RESEARCH IN CLINICAL AMPLIFICTION |
DEN100025 |
K101699 |
03/31/2011 |
CABOCHON SYSTEM
|
CABOCHON AESTHETICS, INC. |
DEN110004 |
K101231 |
07/12/2013 |