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C.R. Bard, Inc. FDA Approvals

0 new drug approvals and 18 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)510(k)Jul 10, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 10, 2026
BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit510(k)May 29, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Unknown (Traditional)	May 29, 2026
Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)510(k)Mar 17, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 17, 2026
Rubber Utility Catheter510(k)Feb 23, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2026
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)510(k)May 15, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 15, 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,510(k)Jan 31, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 31, 2025
Aspirex Thrombectomy System510(k)Mar 31, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 31, 2023
Highlander 014 PTA Balloon Dilatation Catheter510(k)Jan 20, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 20, 2023
WavelinQ Generator510(k)Oct 17, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Oct 17, 2022
Aspirex Thrombectomy System510(k)Jun 21, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 21, 2022
Provena(TM) Midline Catheter510(k)May 13, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	May 13, 2022
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter510(k)May 4, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 4, 2022
Halo One Thin-Walled Guiding Sheath510(k)Sep 23, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 23, 2021
Rotarex Atherectomy System510(k)Sep 14, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 14, 2021
Crosser iQ CTO Recanalization System510(k)Aug 12, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 12, 2021
GlidePath Retro Long-Term Hemodialysis Catheter510(k)Jul 1, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Unknown (Traditional)	Jul 1, 2021
Groshong NXT PICC Catheter510(k)Mar 12, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 12, 2021
Recon Support Catheter510(k)Mar 1, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 1, 2021

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