Data / Medical devices / Evacuator, Vapor, Cement Monomer

Evacuator, Vapor, Cement Monomer (JDY): 18 FDA-registered makers in 7 countries

Name: FDA-registered makers of Evacuator, Vapor, Cement Monomer
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 7 countries are registered with the FDA to make Evacuator, Vapor, Cement Monomer (product code JDY, Class 1, 21 CFR 888.4220). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on January 4, 1991, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: JDY
Device class: 1
Regulation: 888.4220
Medical specialty: Orthopedic

Makers by country

Country	Makers
United States	7
United Kingdom	3
China	3
Germany	2
India	1
Ireland	1
South Korea	1

Makers of Evacuator, Vapor, Cement Monomer

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.

Maker	Location	Role	Recall events	Source
Auxein medical Private limited	Sonipat Haryana, India	Manufacturer	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Specification developer	0	api.fda.gov
Depuy CMW	Blackpool, Lancashire, United Kingdom	Manufacturer, Specification developer	0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer, Specification developer	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0	api.fda.gov
Heraeus Medical GmbH	WEHRHEIM Hesse, Germany	Manufacturer	0	api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Mctbio	Yongin-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Osartis GMBH	Muenster Hesse, Germany	Manufacturer	0	api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Summit Medical Ltd.	Gloucestershire, United Kingdom	Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Zimmer Surgical, Inc.	Dover, OH, United States	Manufacturer	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	1	api.fda.gov

Updated January 4, 1991. 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.