HomeUSAZIMMER MANUFACTURING B.V.

ZIMMER MANUFACTURING B.V.

USA · Mercedita
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 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
28listed device types
Class I 1Class II 27Class III 0
plus 58 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
21registered devices
Class I 6Class II 15
36 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
67 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
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 States58 registration records, 4 510(k), 0 PMA, 49 excluded
Brazil21 confirmed, 20 excluded
Saudi Arabia0 confirmed, 11 excluded
Canada2 confirmed, 15 excluded
Manufacturer names merged into this page: ZIMMER MANUFACTURING B.V. · Zimmer Orthopedics Manufacturing Limited-Galway · ZIMMER SWITZERLAND MANUFACTURING GMBH · ZIMMER ORTHOPEDICS MANUFACTURING LIMITED · Zimmer Orthopedics Manufacturing Limited

Company information

Country
USA
City
Mercedita

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12021 · K212129
12023 · K231114
12024 · K241754
12025 · K253749

FDA listed device types

showing 8 of 28
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Cement Obturator 1Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer 1Washer, Bolt Nut 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253749Affixus® Natural Nail® Proximal Humeral System2025-12-12
USK241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate2024-08-15
USK231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System2023-08-09
BR80044689002INSTRUMENTAIS PARA CIRURGIA DE JOELHO BIOMET®Class I
BR80044680383Instrumentais para Artroplastia RevitanClass II
BR80044680384INSTRUMENTAIS PARA ARTROPLASTIA TOTAL DE QUADRILClass II
CA92290STABILIZATION BOLT FOR TARGETING DEVICEClass II
CA92356TISSUE PROTECTION SLEEVEClass II

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