Orthosis, Cranial, Laser Scan
Regulation 882.5970
0510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OAN
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthomerica Products, Inc. | 17 | 0 |
| Boston Brace Intl., Inc. | 2 | 0 |
| Cranial Technologies, Inc. | 2 | 0 |
| Biosculptor Corporation | 1 | 0 |
| Hanger Prosthetics & Orthotics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2025 | K244056 | DOC Band 3D Cranial Technologies, Inc. | OAN |
| Mar 15, 2024 | K240466 | STARband 3D Orthomerica Products, Inc. | OAN |
| Aug 17, 2021 | K211376 | STARband Orthomerica Products, Inc. | OAN |
| Apr 27, 2021 | K203098 | STARband, STARlight, St. Louis Band Orthomerica Products, Inc. | OAN |
| Mar 1, 2018 | K180109 | STARband, STARlight, St. Louis Band Orthomerica Products, Inc. | OAN |
| Jul 20, 2016 | K161138 | St. Louis Band Orthomerica Products, Inc. | OAN |
| Sep 18, 2015 | K151979 | STARband, STARlight Orthomerica Products, Inc. | OAN |
| Jul 1, 2015 | K151147 | STARband, STARlight Orthomerica Products, Inc. | OAN |
| Apr 23, 2015 | K142141 | STARBAND, STARLIGHT Orthomerica Products, Inc. | OAN |
| Jan 16, 2014 | K133250 | STARLIGHT Orthomerica Products, Inc. | OAN |
| Jun 10, 2013 | K124023 | STARBAND Orthomerica Products, Inc. | OAN |
| Jul 17, 2009 | K090587 | STARLIGHT Orthomerica Products, Inc. | OAN |
| Jan 27, 2009 | K081787 | CAMLAB CRANIAL ORTHOSIS HELMET Biosculptor Corporation | OAN |
| Dec 5, 2008 | K082950 | STARBAND Orthomerica Products, Inc. | OAN |
| Oct 31, 2008 | K082945 | STARLIGHT Orthomerica Products, Inc. | OAN |
| Sep 12, 2008 | K081994 | STARLIGHT Orthomerica Products, Inc. | OAN |
| Jan 22, 2008 | K072862 | BOSTON-BAND CRANIAL REMODLING ORTHOSIS Boston Brace Intl., Inc. | OAN |
| Jan 9, 2008 | K072566 | HANGER CRANIAL BAND Hanger Prosthetics & Orthotics, Inc. | OAN |
| Apr 11, 2007 | K063098 | STATIC CRANIOPLASTY ORTHOSIS Boston Brace Intl., Inc. | OAN |
| Jul 25, 2002 | K021918 | CLARREN HELMET (ORTHOMERICA) Orthomerica Products, Inc. | OAN |
| Jul 9, 2002 | K021207 | STARLIGHT Orthomerica Products, Inc. | OAN |
| Jan 28, 2002 | K014012 | DOC BAND Cranial Technologies, Inc. | OAN |
| Jul 3, 2001 | K011350 | STARBAND CRANIAL ORTHOSIS Orthomerica Products, Inc. | OAN |
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