C.R. Bard, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit, Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories), Rubber Utility Catheter
645
Total
609
Cleared
0
Denied
FDA 510(k) Regulatory Record - C.R. Bard, Inc. General & Plastic Surgery ✕
71 devices
Cleared
Mar 17, 2026
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System...
General & Plastic Surgery
181d
Cleared
Oct 17, 2022
WavelinQ™ Generator
General & Plastic Surgery
31d
Cleared
Jul 17, 2020
3DMax MID Anatomical Mesh
General & Plastic Surgery
109d
Cleared
Jun 12, 2019
Phasix ST Mesh with Open Positioning System
General & Plastic Surgery
131d
Cleared
Dec 14, 2018
Phasix ST Mesh with Echo 2 Positioning System
General & Plastic Surgery
140d
Cleared
Apr 25, 2018
Phasix ST Mesh
General & Plastic Surgery
208d
Cleared
May 31, 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30...
General & Plastic Surgery
121d
Cleared
Apr 11, 2017
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
General & Plastic Surgery
103d
Cleared
Sep 29, 2016
Phasix Mesh
General & Plastic Surgery
129d
Cleared
May 31, 2016
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners,...
General & Plastic Surgery
60d
Cleared
May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix...
General & Plastic Surgery
186d
Cleared
Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
General & Plastic Surgery
261d
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