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Davol, Inc.

USA · Woburn

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Hong Kong, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 1Class II 3Class III 2unclassified 1

plus 5 registration records and 50 510(k), 41 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

12device registrations

CLASS B 1CLASS C 4CLASS D 7

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

Class III 2Class IV 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 2b 1Class 3 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 50 510(k), 41 PMA, 6 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: DAVOL INC. · DAVOL INC

FDA 510(k) clearances by year

11977

41978

41979

11980

11989

51990

101991

91992

41993

51994

12000

12001

22003

22025

FDA listed device types

Agent, Absorbable Hemostatic, Collagen Based 1Agent, Absorbable Hemostatic, Non-Collagen Based 1Splint, Intranasal Septal 1Polymer, Ear, Nose And Throat, Synthetic, Absorbable 1Mesh, Surgical, Absorbable, Abdominal Hernia 1Surgical Film 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1

Market	Identifier	Name	Class / date
US	K251557	Bard® Mesh; Bard® Mesh Pre-Shaped	2025-06-12
US	K250098	Bard Soft Mesh; Bard Soft Mesh Pre-Shaped	2025-04-09
US	K031213	AQUASENS FLUID MONITORING SYSTEM	2003-04-30

Davol, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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