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Data / Medical devices / Clamp, Umbilical

Clamp, Umbilical (HFW): 36 FDA-registered makers in 12 countries

36 establishments in 12 countries are registered with the FDA to make Clamp, Umbilical (product code HFW, Class 2, 21 CFR 884.4530). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on June 25, 2004, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
HFW
Device class
2
Regulation
884.4530
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
China11
United States9
India4
Israel2
Pakistan2
Mexico2
Germany1
Malaysia1
Taiwan1
Honduras1
Indonesia1
Vietnam1

Makers of Clamp, Umbilical

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
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelSpecification developer2April 27, 2000000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer, Specification developer1October 17, 1978000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler1April 30, 2001000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Advanced Product Solutions Inc.Dothan, AL, United StatesContract manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Anhui Ares Medical Technology Co.,ltd.Tianchang Anhui, ChinaManufacturer0000api.fda.gov
Anhui Medpurest Medical Technology Co.,ltdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anqing Kangmingna Packaging Co.,ltdAnqing Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Diatrust Medical Co., Ltd.Nanjing City Jiangsu, ChinaManufacturer0000api.fda.gov
Disposafe Health And Life Care LimitedFaridabad Haryana, IndiaManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Hantech Medical Device Co., Ltd.Cixi Zhejiang, ChinaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.YANGZHOU CITY, Jiangsu, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu Suyun Medical Materials Co., Ltd.Lianyungang, Jiangsu, ChinaManufacturer0000api.fda.gov
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.Jingmen City Hubei, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangxi Yiles Medical Co., LtdNanchang City Jiangxi, ChinaManufacturer0000api.fda.gov
Lamed Private LimitedFARIDABAD Haryana, IndiaManufacturer0000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Pollak (intl.).ltdTel Aviv, IsraelComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
PT. Jayamas Medica Industri TbkSidoarjo Jawa Timur, IndonesiaContract manufacturer0000api.fda.gov
Stevimed Medical Joint Stock CompanyCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Suministros Y Desechables Skkyd S.A. De C.V.Naucalpan Estado de Mexico, MexicoExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Suru International Pvt LtdDAHANU Maharashtra, IndiaManufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Thunderbird Molding GreensboroGreensboro, NC, United StatesContract manufacturer0000api.fda.gov
Weihai Hongyu Nonwoven Fabric Products Co.,LtdWeihai Shandong, ChinaManufacturer0000api.fda.gov

Updated June 25, 2004. 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.