FDA 510(k) Applications Submitted by JAMES W HART
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220527 |
02/24/2022 |
PADnet Xpress |
Collaborative Care Diagnostics LLC, d.b.a. Biomedix |
| K051397 |
05/27/2005 |
BIOBANDS |
BIOBANDS DISTRIBUTORS, INC. |
| K030170 |
01/17/2003 |
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 |
OPUS MEDICAL, INC. |
| K031083 |
04/04/2003 |
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 |
OPUS MEDICAL, INC. |
| K022229 |
07/10/2002 |
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 |
OPUS MEDICAL, INC. |
| K023843 |
11/18/2002 |
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE |
OPUS MEDICAL, INC. |
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