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Davol Inc.

Last updated September 17, 2026

Information

Country: US
Address: 160 New Boston St, WOBURN, MA, 01801
Website: bd.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)562-0027
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000120505
DUNS Number: 001191048

Catalogue (449)

Page 9 of 9

Device	Model / Reference	Registries	Class	Status
Davol Implant Ports W/Attach Hi Perf Groshong Cath	K913235	FDA 510(k)	Class II	Active
Davol Cardiovascular Autotransfusion Unit	K931552	FDA 510(k)	Class II	Active
Bard Laparoscopic Irrigator Pump System	K902722	FDA 510(k)	Class II	Active
Davol Laparoscopic Instruments (gen Surg Reusable)	K914910	FDA 510(k)	Class II	Active
Round Silicone Drain	K782028	FDA 510(k)	Class I	Active
Davol Arthrovent Outflow Tubing	K030307	FDA 510(k)	Class II	Active
Thora-Klex Chest Drainage Unit	K905448	FDA 510(k)	Class II	Active
Davol Endo-Flo Laser Probe And Accessories	K920659	FDA 510(k)	Class II	Active
Bubble Suction Tubing	K780724	FDA 510(k)	Class II	Active
Surgical Mesh Delivery System, General Surgery	K930147	FDA 510(k)	Class II	Active
Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005	K003790	FDA 510(k)	Class II	Active
Davol Ats	K931899	FDA 510(k)	Class II	Active
Arthro-Flow Irrigation 2 System	K913028	FDA 510(k)	Class II	Active
Composix Kugel Mesh, Model 0010201, 0010202, 0010203, 0010204, 0010205	K003323	FDA 510(k)	Class II	Active
Ellik Evacuator	K791306	FDA 510(k)	Class II	Active
Davol Laparoscopic Insufflation Tubing Set	K935503	FDA 510(k)	Class II	Active
Davol Suction/Irrigator W/ Interchangeable Tip	K921405	FDA 510(k)	Class II	Active
T-Tube Whelan-Moss	K772292	FDA 510(k)	Class II	Active
Usher's Marlex Tubular Mesh	K792281	FDA 510(k)	Class II	Active
Davol Knot Pusher	K924592	FDA 510(k)	Class II	Active
8 Fr Single Lumen High Perf. Groshong Cent. Venous	K921755	FDA 510(k)	Class II	Active
Davol Laparoscopic Suction Irrigation Probe	K941334	FDA 510(k)	Class II	Active
Dual Lumen 5 Fr Perip Cent Ven Cath W/Groshong Val	K904558	FDA 510(k)	Class II	Active
Aquasens Fluid Monitoring System	K031213	FDA 510(k)	Class II	Active
Bard Laparoscopic Irrigator Pump System	K926479	FDA 510(k)	Class II	Active
Davol Laparoscopic Loop And Retrieval Devices	K922526	FDA 510(k)	Class II	Active
Davol Arthroscopy Cannula	K894990	FDA 510(k)	Class II	Active
Flat Silicone Drain	K782026	FDA 510(k)	Class I	Active
Davol Electrosugical Probes	K915406	FDA 510(k)	Class II	Active
8 Fr Single Lumen High Performance Catheter	K910486	FDA 510(k)	Class II	Active
Davol Laparoscopic Cholangiogram Catheter & Kit	K914755	FDA 510(k)	Class II	Active
Davol Endo-Flo Suct/Irri Probe (for Gen Surgery)	K914526	FDA 510(k)	Class II	Active
Laparoscopic Aspiration Probe	K910340	FDA 510(k)	Class II	Active
Davol 100cc Silicone Closed Wound Drainage Evac	K915536	FDA 510(k)	Class I	Active
Davol Orthopaedic Autotransfusion System	K914119	FDA 510(k)	Class II	Active
Bard Soft Mesh; Bard Soft Mesh Pre-Shaped	K250098	FDA 510(k)	Class II	Active
Plastic Attachable Dual Port	K912702	FDA 510(k)	Class II	Active
Bard® Mesh; Bard® Mesh Pre-Shaped	K251557	FDA 510(k)	Class II	Active
Davol Post-Op Autotransfusion System	K913684	FDA 510(k)	Class II	Active
Davol/Simon Dermatome	K792332	FDA 510(k)	Class I	Active
Endoscopic Carpal Tunnel Release System (ctr)	K924144	FDA 510(k)	Class II	Active
Davol Autotransfusion Blood Processing System	K901401	FDA 510(k)	Class II	Active
Pediatric And Infant Cath Kits	K905016	FDA 510(k)	Class II	Active
Thora-Klex Chest Drainage Unit	K896127	FDA 510(k)	Class II	Active
Percutaneous Introducers	K903530	FDA 510(k)	Class II	Active
Thora-Klex 350 Ml Pediatric Chest Drainage System	K932327	FDA 510(k)	Class II	Active
Arthroscopy Instrument Cannula	K911205	FDA 510(k)	Class II	Active
Hysterectomy T Drain	K782027	FDA 510(k)	Class II	Active
Arista™ AH	P050038	FDA PMA	Class III	Active

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 25, 2026	Z-1896-2026	—	open, classified	Potential for product to contain foreign matter, confirmed to be inspect fragments.
Apr 25, 2023	Z-2242-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Apr 25, 2023	Z-2241-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Apr 25, 2023	Z-2244-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Apr 25, 2023	Z-2243-2023	—	open, classified	Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Jun 27, 2022	Z-1457-2022	—	open, classified	The device may potentially cause a fire, leading to a safety risk.
Jun 7, 2022	Z-1305-2022	—	open, classified	The product is not able to provide irrigation.
Jun 7, 2022	Z-1304-2022	—	open, classified	The product is not able to provide irrigation.