C. R. Bard is one of 13048 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
C. R. Bard - FDA 510(k) Cleared Devices
Recent clearances: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters, Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech, ULTRASCORE Focused Force PTA Balloon
9
Total
8
Cleared
0
Denied
C. R. Bard has 8 FDA 510(k) cleared medical devices. Based in Salt Lake Ciy,, US.
Historical record: 8 cleared submissions from 2012 to 2020. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by C. R. Bard Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bard Access Systems, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - C. R. Bard
9 devices
Cleared
Mar 05, 2020
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis...
Gastroenterology & Urology
367d
Cleared
Oct 24, 2018
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT...
Radiology
62d
Cleared
Sep 22, 2017
ULTRASCORE Focused Force PTA Balloon
Cardiovascular
25d
Cleared
May 01, 2017
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle,...
General & Plastic Surgery
90d
Cleared
Dec 23, 2016
XenMatrix AB Surgical Graft
General & Plastic Surgery
141d
Cleared
Jul 30, 2015
XenMatrix AB Surgical Graft
General & Plastic Surgery
90d
Cleared
Mar 31, 2015
Phasix Mesh
General & Plastic Surgery
183d
Cleared
Apr 28, 2014
XENMATRIX SURGICAL GRAFT
General & Plastic Surgery
60d
Cleared
Feb 24, 2012
SITESCRUB IPA DEVICE
General Hospital
151d