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Data / Medical devices / Dislodger, Stone, Basket, Ureteral, Metal

Dislodger, Stone, Basket, Ureteral, Metal (FFL): 62 FDA-registered makers in 14 countries

62 establishments in 14 countries are registered with the FDA to make Dislodger, Stone, Basket, Ureteral, Metal (product code FFL, Class 2, 21 CFR 876.4680). 2 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on July 18, 2019, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FFL
Device class
2
Regulation
876.4680
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States18
China16
Germany10
Japan4
India4
Costa Rica2
Egypt1
France1
Switzerland1
Netherlands1
Turkey1
Mexico1
United Kingdom1
Monaco1

Makers of Dislodger, Stone, Basket, Ureteral, Metal

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
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1September 12, 1983000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1September 12, 1983000api.fda.gov
Ameco Medical Industries10TH OF RAMADAN CITY Ash Sharqiyah, EgyptContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Angiomed GMBH & Co. Medizintechnik KGKARLSRUHE Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Annex Medical, Inc.Minnetonka, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer0000api.fda.gov
Alleima Karlsruhe GmbHKarlsruhe Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Auris Health, IncSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Auris Health, Inc.San Jose, CA, United StatesManufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
Biorad Medisys Pvt. Ltd.Pune Maharashtra, IndiaManufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0010api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0020api.fda.gov
Changzhou Health Microport Medical Device Co.,ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Coloplast Manufacturing France, SASSarlat la Caneda Cedex Dordogne, FranceManufacturer0000api.fda.gov
Dongguan ZSR Biomedical Technology Company LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Epflex Feinwerktechnik GMBHDETTINGEN/ERMS Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
EndoTheia, Inc.Nashville, TN, United StatesSpecification developer0000api.fda.gov
Fukuda Denshi Co., Ltd.Shiroi-shi Chiba, JapanManufacturer0000api.fda.gov
Fukuda Denshi Co., Ltd.Bunkyo-ku Tokyo, JapanSpecification developer0000api.fda.gov
Gimmi GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Goodwill Commercial ServicesIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Grace Manufacturing IncRussellville, AR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesManufacturer0000api.fda.gov
H.+H. Maslanka Chirurgische Instrumente GmbHTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Horizons Intl. Corp.Heredia, Costa RicaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Hunan Endoso Life Technology Co., LtdXiangTan Hunan, ChinaManufacturer0000api.fda.gov
Jiangsu Grit Medical Technology Co., Ltd.changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.Ji 'an Jiangxi, ChinaManufacturer0000api.fda.gov
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Marflow AGISLIKON Thurgau, SwitzerlandManufacturer0000api.fda.gov
Med Pro Medical B.VVeenendaal Utrecht, NetherlandsSpecification developer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.Tuzla Istanbul, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Productos Para El Cuidado De La SaludNOGALES Sonora, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Rocamed SamMONACO Monaco-Ville, MonacoManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Seplou (zhuhai) Co.,ltd.Zhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Trious Medical Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Suru International Pvt LtdDAHANU Maharashtra, IndiaManufacturer0000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Wilson Instruments (sha) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Yigao Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov

Updated July 18, 2019. 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.