Rex Medical, L.P. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Rex Medical, L.P. - FDA 510(k) Cleared Devices
Recent clearances: Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire, Rex Medical Aspiration Pump
8
Total
8
Cleared
0
Denied
Rex Medical, L.P. has 8 FDA 510(k) cleared medical devices. Based in Great Neck, US.
Last cleared in 2021. Active since 2004. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Rex Medical, L.P. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mdi Consultants, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Rex Medical, L.P.
8 devices
Cleared
Dec 15, 2021
Revolution Peripheral Atherectomy System
Cardiovascular
139d
Cleared
CT
Sep 12, 2019
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy...
Cardiovascular
107d
Cleared
Jan 30, 2018
Rex Medical Aspiration Pump
General & Plastic Surgery
92d
Cleared
Apr 16, 2015
Option (TM) ELITE Vena Cava Filter 100cm System
Cardiovascular
139d
Cleared
Nov 14, 2014
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Cardiovascular
150d
Cleared
Dec 17, 2013
OPTION ELITE VENA CAVA FILTER SYSTEM
Cardiovascular
56d
Cleared
Apr 28, 2006
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Cardiovascular
25d
Cleared
Dec 17, 2004
MODIFICATION TO SHORT INTRODUCER SHEATH
Cardiovascular
105d