DAVOL INC.

FDA Device Registration & Listing · WOBURN, MA, US · Registration 1223089

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
1223089
FEI Number
1000120505
Entity Name
DAVOL INC.
City/State/Country
WOBURN, MA, US
Establishment Address
160 New Boston St, WOBURN, MA 01801, US
Establishment Type(s)
Manufacture Medical Device
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
P800002

All Registered Proprietary Names

HemaDERM Phasix Avitene Ultrafoam Avitene

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2015-01-14
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2015-01-14
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2015-01-14
OWT Mesh, Surgical, Absorbable, Abdominal Hernia General, Plastic Surgery Class 2 878.3300 2013-03-01
OOD Surgical Film General, Plastic Surgery Class 2 878.3300 2013-03-01
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2008-05-02
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2008-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3002504068 Bard European Distribution Center NV Olen Antwerpen, BE
1213643 DAVOL INC., SUB. C.R. BARD, INC. Warwick, RI, US
1424526 BARD BRACHYTHERAPY, INC CAROL STREAM, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220566 Koag, LLC Vascette HP (hemostatic pad) 2022-07-29
K080818 Hem Con Medical Technologies, Inc. HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING 2008-05-15
K893123 Les Laboratorires Brothier, S.A. ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES 1990-02-13
K143462 Benq Materials Corporation AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) 2015-05-08
K040208 Tz Medical, Inc. NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND 2004-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223089. Last updated year: 2026. Please use registration number 1223089 when referencing this establishment in official correspondence.
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