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Opus Medical, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K042584 OPUS MINIMAGNUM ANCHOR WITH INSERTERHWC2004-12-14 View
510(k) K042914 OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEMBI2004-11-12 View
510(k) K042031 OPUS SPEEDSTITCH SUTURE DEVICEGAT2004-10-19 View
510(k) K041440 OPUS MAGNUM ANCHOR WITH INSERTERMBI2004-06-25 View
510(k) K033317 SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070OCW2003-12-30 View
510(k) K030170 REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500OCW2003-07-28 View
510(k) K031083 OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500HTY2003-06-12 View
510(k) K030235 F1 DIODE LASER SYSTEMGEX2003-04-23 View
510(k) K023843 SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGEOCW2003-02-14 View
510(k) K022229 SMARTSTITCH SUTURE DEVICE, MODEL OM-8500OCW2002-09-06 View
510(k) K020172 OPUS MAGNUM ANCHOR & INSTRUMENT SETMBI2002-07-22 View
510(k) K012125 OPUS MAGNUM ANCHOR & INSERTERHTY2001-09-17 View
510(k) K004021 F1 DIODE LASER SYSTEMGEX2001-03-27 View
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