Medical Device Manufacturer · US , Ridgefield , CT

Goodman Co., Ltd.

3 submissions · 3 cleared · Since 2001

Total

Cleared

Denied

Goodman Co., Ltd. — FDA 510(k) Submissions

Goodman Co., Ltd. has submitted 3 FDA 510(k) premarket notifications since 2001, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Cutting/scoring, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

3 devices

1–3 of 3

Aperta NSE PTA Balloon Dilatation Catheter

K243944 · PNO Catheter, Percutaneous,... · Cardiovascular

Apr 2025 123d

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)

K232013 · PNO Catheter, Percutaneous,... · Cardiovascular

Mar 2024 266d

GOODNET

K010763 · LLZ System, Image Processing,... · Radiology

May 2001 72d