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Zimmer Orthopaedic Surgical Products

USA · Dover

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore — 5 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

34listed device types

Class I 22Class II 12Class III 0

plus 47 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 2Class II 16

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

SASaudi ArabiaSFDA

39registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 2CLASS C 2

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 States47 registration records, 2 510(k), 0 PMA, 48 excluded

Brazil18 confirmed, 21 excluded

Saudi Arabia39 confirmed, 7 excluded

Canada0 confirmed, 15 excluded

Manufacturer names merged into this page: ZIMMER SURGICAL, INC. · ZIMMER SURGICAL SA · ZIMMER SURGICAL, INC · Zimmer Surgical Inc. · Zimmer Surgical S.A. · Zimmer Surgical SA

FDA 510(k) clearances by year

12005 · K050433

12019 · K192194

FDA listed device types

showing 8 of 34

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Sleeve, Limb, Compressible 1Gown, Surgical 1Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Prosthesis, Elbow, Semi-Constrained, Cemented 1Prosthesis, Elbow, Constrained, Cemented 1Hood, Surgical 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192194	TotalShield II Surgical Helmet System	2019-10-15
US	K050433	ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM	2005-04-13
BR	80012450031	LÂMINAS DE SERRA PARA PERFURADORES ÓSSEOS	Class II
BR	80044689049	Sistema de Torniquete	Class II
BR	80044680245	Lâminas de Serra Oxford	Class II
SA	ME0000003720SFDAA00001	Oscillating Saw Blade Cutting Fits Zimmer Biomet X Series	—
SA	ME0000003717SFDAA00001	Oscillating Saw Blade Cutting Fits Zimmer Biomet X Series	—

Zimmer Orthopaedic Surgical Products

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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