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Data / Medical devices / Mixer, Cement, For Clinical Use

Mixer, Cement, For Clinical Use (JDZ): 74 FDA-registered makers in 16 countries

74 establishments in 16 countries are registered with the FDA to make Mixer, Cement, For Clinical Use (product code JDZ, Class 1, 21 CFR 888.4210). 3 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on April 29, 1994, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
JDZ
Device class
1
Regulation
888.4210
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States27
China12
South Korea5
Germany5
Malaysia4
Italy3
Taiwan3
Switzerland3
Mexico3
United Kingdom2
France2
India1
Ireland1
Turkey1
Brazil1
Hong Kong1

Makers of Mixer, Cement, For Clinical Use

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer1January 5, 1994000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer1August 29, 1991000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1August 29, 1991000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaManufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov
Biopsybell S.R.L.MIRANDOLA Modena, ItalyManufacturer0000api.fda.gov
BM Korea Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
CDM Center Of Excellence Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandSpecification developer0000api.fda.gov
Depuy CMWBlackpool, Lancashire, United KingdomManufacturer, Specification developer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Dongguan Kaiser Technology Co., LtdDongguan city Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Formosa Biomedical Technology CorporationTaipei, TaiwanManufacturer0000api.fda.gov
G21 S.R.I.San Possidonio Modena, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Guangzhou Clean Medical Products Manufacturing CorpGuangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huizhou Videya Technology Co., Ltd.Huizhou Guangdong, ChinaManufacturer0000api.fda.gov
Heraeus Medical GmbHWEHRHEIM Hesse, GermanyManufacturer0010api.fda.gov
Hicren (Zhejiang) Medtech Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Imedicom Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer0000api.fda.gov
Indusbello Industria De Instrumentos OdoLondrina Parana, BrazilManufacturer0000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer0000api.fda.gov
Jie Gao Medical Plastic Products (malaysia) Sdn. Bhd.Klang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Jie Gao Plastic Products Co., Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Joline GMBH & Co. KGHECHINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Le Locle)Le Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
MctbioYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Monitex Industrial Co., Ltd.SAN-CHUNG CITY Taipei, TaiwanContract manufacturer0000api.fda.gov
Motion Dental Equipment CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Orthotech Co., Ltd.Dong-Gu Daegu, South KoreaManufacturer0000api.fda.gov
Osartis GMBHMuenster Hesse, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Premium Plus International LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Seawon Meditech Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Spang & Brands GMBHFriedrichsdorf Hesse, GermanyContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Summit Medical Ltd.Gloucestershire, United KingdomManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stryker Tijuana OperationsTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
Tecres SPAVERONA Veneto, ItalyManufacturer0000api.fda.gov
Teknimed SASL Union Haute-Garonne, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Tornier S.A.S.Montbonnot Saint-Martin Isere, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Viant Mexicana de Servicios, S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov

Updated April 29, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.