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Data / Medical devices / Holder, Head, Radiographic

Holder, Head, Radiographic (IWY): 24 FDA-registered makers in 6 countries

24 establishments in 6 countries are registered with the FDA to make Holder, Head, Radiographic (product code IWY, Class 1, 21 CFR 892.1920). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on December 28, 1992, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
IWY
Device class
1
Regulation
892.1920
Medical specialty
Radiology

Makers by country

CountryMakers
United States13
China4
Israel3
Germany2
Taiwan1
Switzerland1

Makers of Holder, Head, Radiographic

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
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer0000api.fda.gov
Beijing Health Medical Technology Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Blessing Cathay CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
Baxter Medical Systems GmbH + Co. KGSAALFELD Thuringia, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Cassemco, Inc.Cookeville, TN, United StatesContract manufacturer0000api.fda.gov
Creative Foam Corporation - BremenBremen, IN, United StatesContract manufacturer0000api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Domico Med-Device, LLCFenton, MI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ge Medical Systems Israel, Functional ImagingTIRAT HACARMEL Haifa, IsraelManufacturer0000api.fda.gov
Ge Medical Systems Israel, Functional ImagingHaifa, IsraelSpecification developer0000api.fda.gov
GE Medical Systems Israel, Functional ImagingHaifa, IsraelManufacturer0000api.fda.gov
Guangdong Meicen Medical Equipment Co., Ltd.foshan Guangdong, ChinaManufacturer0000api.fda.gov
Hyperfine, IncGuilford, CT, United StatesManufacturer, Specification developer0000api.fda.gov
Klarity Medical & Equipment (GZ) Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Klarity Medical Products, LLCHeath, OH, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Maquet GMBHRASTATT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Medtec LLCOrange City, IA, United StatesManufacturer0000api.fda.gov
Neocis IncMiami, FL, United StatesSpecification developer0000api.fda.gov
Pearl Technology AGSchlieren Zurich, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Radiation Products Design, Inc.Albertville, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Tengfei Yu Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer0000api.fda.gov
Techno-Aide, Inc.Whites Creek, TN, United StatesManufacturer0000api.fda.gov
Xoran Technologies, LLCAnn Arbor, MI, United StatesManufacturer0000api.fda.gov

Updated December 28, 1992. 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.