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Biomet Manufacturing, Inc.

USA · Warsaw

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

131510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 131 510(k), 106 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States0 registration records, 131 510(k), 106 PMA, 52 excluded

Brazil2 confirmed, 29 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada0 confirmed, 15 excluded

Manufacturer names merged into this page: BIOMET MANUFACTURING, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230540	Patient Specific Planning Solution 3D Bone Models	2023-07-25
US	K214001	Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System	2023-03-15
US	K211729	Comprehensive® Convertible Glenoid - Vivacit-E Liner	2021-11-04
BR	80044689032	Kit de Cânula Descartável Juggerloc	Class II
BR	80044680528	Instrumentais do Sistema de Recuperação Ortopédica OSS	Class I

Biomet Manufacturing, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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