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Precision Medical Devices, Inc.

USA · New Brunswick

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Israel — 3 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

22listed device types

Class I 20Class II 2Class III 0

plus 22 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States22 registration records, 3 510(k), 0 PMA, 278 excluded

Brazil0 confirmed, 27 excluded

Saudi Arabia0 confirmed, 9 excluded

Canada0 confirmed, 12 excluded

Manufacturer names merged into this page: Precision Medical Devices Inc · PRECISION MEDICAL DEVICES, LLC

FDA 510(k) clearances by year

21984 · K840856

11986 · K863854

FDA listed device types

showing 8 of 22

Container, Specimen, Sterile 1Glutaraldehyde 1Dish, Tissue Culture 1Blade, Scalpel 1Cassettes, Tissue 1Clamp, Surgical, General & Plastic Surgery 1Punch, Surgical 1Slides, Microscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K863854	P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG	1986-11-19
US	K840856	MODULAR CONSTRUCT FRAME EXTERNAL FIXA	1984-04-25
US	K840046	PRESSURIZING/SCAVENGING ACRYLIC CEMENT	1984-02-09

Precision Medical Devices, 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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