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Goodman Co., Ltd.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest Approval2025-04-22
TypeNumberDevice NameCodeDate
510(k) K243944 Aperta NSE PTA Balloon Dilatation Catheter PNO 2025-04-22 View
PMA P230026 Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX 2024-08-02 View
510(k) K232013 Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) PNO 2024-03-28 View