Medical Device Manufacturer · US , Great Neck , NY

Rex Medical - FDA 510(k) Cleared Devices

13 submissions · 11 cleared · Since 2003

13

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rex Medical Cardiovascular ✕

10 devices

1-10 of 10

Cleared Jun 01, 2012

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Cardiovascular · 119d

Cleared May 22, 2012

SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE

Cardiovascular · 216d

Cleared Feb 18, 2010

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)

Cardiovascular · 314d

Cleared Jun 04, 2009

OPTION VENA CAVA FILTER

Cardiovascular · 380d

Cleared Aug 04, 2005

INNER-LOCK INTRODUCER SHEATH

Cardiovascular · 62d

Cleared Feb 26, 2004

CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT

Cardiovascular · 22d

Cleared Dec 16, 2003

CLEANER II ROTATIONAL THROMBECTOMY SYSTEM

Cardiovascular · 11d

Cleared Sep 16, 2003

SHORT INTRODUCER SHEATH

Cardiovascular · 27d

Cleared May 27, 2003

REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Cardiovascular · 5d

Cleared Jan 21, 2003

INNER-LOCK LOCKING INTRODUCER SHEATHS

Cardiovascular · 202d