Medical Device Manufacturer · US , Salt Lake Ciy, , UT

C. R. Bard

9 submissions · 8 cleared · Since 2012
9
Total
8
Cleared
0
Denied

C. R. Bard — FDA 510(k) Submissions

C. R. Bard has submitted 9 FDA 510(k) premarket notifications since 2012, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Collagen Surgical Mesh Containing Drugs, Catheter, Percutaneous, Cutting/scoring, System, Imaging, Pulsed Echo, Ultrasonic, Catheter, Hemodialysis, Implanted, Pad, Alcohol, Device Disinfectant . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
K190527 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Mar 2020 367d
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
K182281 · IYO System, Imaging, Pulsed... · Radiology
Oct 2018 62d
ULTRASCORE Focused Force PTA Balloon
K172571 · PNO Catheter, Percutaneous,... · Cardiovascular
Sep 2017 25d
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5?) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4?x 6?) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6?) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6?x8?) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6?x10?) Oval
K170294 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
May 2017 90d
XenMatrix AB Surgical Graft
K162193 · PIJ Collagen Surgical Mesh... · General & Plastic Surgery
Dec 2016 141d
XenMatrix AB Surgical Graft
K151177 · PIJ Collagen Surgical Mesh... · General & Plastic Surgery
Jul 2015 90d
Phasix Mesh
K142818 · OOD Surgical Film · General & Plastic Surgery
Mar 2015 183d
XENMATRIX SURGICAL GRAFT
K140501 · FTM Mesh, Surgical · General & Plastic Surgery
Apr 2014 60d
SITESCRUB IPA DEVICE
K112791 · LKB Pad, Alcohol, Device... · General Hospital
Feb 2012 151d
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