Medical Device Manufacturer · US , Rockville , MD

Jomed, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2001

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Jomed, Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jun 23, 2003

JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900

Cardiovascular · 55d

Cleared May 28, 2003

IN-VISION IMAGING SYSTEM

Cardiovascular · 48d

Cleared May 14, 2003

JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS...

Cardiovascular · 22d

Cleared Dec 16, 2002

JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000,...

Cardiovascular · 118d

Cleared May 17, 2002

SMARTWIRE/SMARTMAP PRESSURE SYSTEM

Cardiovascular · 30d

Cleared Jan 18, 2001

Cardiovascular · 29d