FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K081787 |
BIOSCULPTOR CORPORATION |
CAMLAB CRANIAL ORTHOSIS HELMET |
01/27/2009 |
K072862 |
BOSTON BRACE INTL., INC. |
BOSTON-BAND CRANIAL REMODLING ORTHOSIS |
01/22/2008 |
K063098 |
BOSTON BRACE INTL., INC. |
STATIC CRANIOPLASTY ORTHOSIS |
04/11/2007 |
K014012 |
CRANIAL TECHNOLOGIES, INC. |
DOC BAND |
01/28/2002 |
K072566 |
HANGER PROSTHETICS & ORTHOTICS, INC. |
HANGER CRANIAL BAND |
01/09/2008 |
K211376 |
Orthomerica Products Inc. |
STARband |
08/17/2021 |
K203098 |
Orthomerica Products Inc. |
STARband, STARlight, St. Louis Band |
04/27/2021 |
K180109 |
Orthomerica Products, Inc |
STARband, STARlight, St. Louis Band |
03/01/2018 |
K021918 |
ORTHOMERICA PRODUCTS, INC. |
CLARREN HELMET (ORTHOMERICA) |
07/25/2002 |
K161138 |
ORTHOMERICA PRODUCTS, INC. |
St. Louis Band |
07/20/2016 |
K124023 |
ORTHOMERICA PRODUCTS, INC. |
STARBAND |
06/10/2013 |
K082950 |
ORTHOMERICA PRODUCTS, INC. |
STARBAND |
12/05/2008 |
K011350 |
ORTHOMERICA PRODUCTS, INC. |
STARBAND CRANIAL ORTHOSIS |
07/03/2001 |
K142141 |
ORTHOMERICA PRODUCTS, INC. |
STARBAND, STARLIGHT |
04/23/2015 |
K151147 |
ORTHOMERICA PRODUCTS, INC. |
STARband, STARlight |
07/01/2015 |
K151979 |
ORTHOMERICA PRODUCTS, INC. |
STARband, STARlight |
09/18/2015 |
K081994 |
ORTHOMERICA PRODUCTS, INC. |
STARLIGHT |
09/12/2008 |
K090587 |
ORTHOMERICA PRODUCTS, INC. |
STARLIGHT |
07/17/2009 |
K021207 |
ORTHOMERICA PRODUCTS, INC. |
STARLIGHT |
07/09/2002 |
K082945 |
ORTHOMERICA PRODUCTS, INC. |
STARLIGHT |
10/31/2008 |
K133250 |
ORTHOMERICA PRODUCTS, INC. |
STARLIGHT |
01/16/2014 |