DAVOL SURGICAL INNOVATIONS

FDA Device Registration & Listing · CD. JUAREZ Chihuahua, MX · Registration 9616067

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616067
FEI Number
3001436772
Entity Name
DAVOL SURGICAL INNOVATIONS
City/State/Country
CD. JUAREZ Chihuahua, MX
Establishment Address
AVE. ROBERTO FIERRO No. 6408/6123, PARQUE IND. AEROPUERTO, CD. JUAREZ Chihuahua --, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
C. R. Bard, Inc. (Owner Number: 2212754)
Owner / Operator Contact Address
1 Becton Drive, Franklin Lakes, NJ 07417, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stabilization Device Statlock Endotracheal Tube Statlock Foley Catheter Stabilization Device Intravascular Catheter Securement Device Sentrinex™ 3D Port Dressing Statlock Stabilization Device Accessory - Foam Strips Sensor Holder Wound Closure Tape Strips AllPoints™ Dressing Change Kit Site Scrub IPA Device Hydro-Surg Hydro-Surg Bard Malleable Tip Catheter Stylet "J" Guidewires Bard Nitinol Guidewires Hyrdo-Glide Guidewire Bard Van Buren Curve Catheter Style NiCore Nitinol Guidewires Clear Advantage ULtraflex Natural Aurora Transfix Wideband PopOn Spirit Bard Woven Phillips Follower PHILLIPS AND HEYMAN Bard Heyman Follower Straight Tip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2009-04-24
EYJ Holder, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2008-03-31
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2006-10-31
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2008-08-29
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2023-05-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-09
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2013-05-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-09
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2007-03-14
NNX Device, Incontinence, Urosheath Type, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2014-10-26
FBW Filiform And Filiform Follower Gastroenterology, Urology Class 1 876.5520 2007-03-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-05-31

Official Correspondent

No official correspondent registered.

US Agent Details

Joni Anderson Business: BD Email: Joni.Anderson@bd.com Phone: (480) 2662981

Related Public Records

Same Entity

C. R. Bard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1725056 MEDIVANCE, INC. LOUISVILLE, CO, US
3006513822 Lutonix, Inc. Tempe, AZ, US
1223089 DAVOL INC. WOBURN, MA, US
3002504068 Bard European Distribution Center NV Olen Antwerpen, BE
1213643 DAVOL INC., SUB. C.R. BARD, INC. Warwick, RI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616067. Last updated year: 2026. Please use registration number 9616067 when referencing this establishment in official correspondence.
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