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Data / Medical devices / Forceps, Biopsy, Non-Electric

Forceps, Biopsy, Non-Electric (FCL): 130 FDA-registered makers in 19 countries

130 establishments in 19 countries are registered with the FDA to make Forceps, Biopsy, Non-Electric (product code FCL, Class 1, 21 CFR 876.1075). 5 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 39 510(k) clearances under this code, the latest on July 16, 2003, and lists 4 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
FCL
Device class
1
Regulation
876.1075
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
Germany35
China35
United States22
Pakistan15
South Korea3
Japan3
Costa Rica2
Ireland2
Australia2
Italy2
Thailand1
India1
Belgium1
Mexico1
Denmark1
Poland1
Vietnam1
Brazil1
United Kingdom1

Makers of Forceps, Biopsy, Non-Electric

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
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer2July 16, 2003000api.fda.gov
Endo-Therapeutics, Inc.Clearwater, FL, United StatesManufacturer1November 5, 1993000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1January 25, 1994000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer1September 15, 1997010api.fda.gov
Zinnanti Surgical Design Group IncSanta Cruz, CA, United StatesSpecification developer1October 3, 1989000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Ags Medtech (thailand) Co., Ltd.Pluak Daeng District Rayong, ThailandManufacturer, Repackager or relabeler0000api.fda.gov
AlframedSialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Alton Shanghai Medical Instruments Co LtdShanghai, ChinaManufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Anrei Medical (Hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Bacher Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Health Microport Medical Device Co.,ltd.Changzhou Jiangsu, ChinaContract sterilizer, Exporter to the US, Manufacturer0000api.fda.gov
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Jiuhong Medical Instrument Co., Ltd.CHANGZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Lookmed Medical Instrument Co.,ltdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Newmed Micro-Medtech Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Cook Ireland LtdLIMERICK Limerick(County), IrelandComplaint file establishment, Manufacturer0000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Diversatek Healthcare IncMilwaukee, WI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dufner Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Denzel Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
EFINGER INSTRUMENTS GmbH & Co. KGSPAICHINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
FinemedixDaegu Gwangyeogsi, South KoreaManufacturer0000api.fda.gov
FRITZ HUBER GmbH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanComplaint file establishment, Specification developer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G-Flex Europe SRLNivelles Brabant Wallon, BelgiumSpecification developer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gebrueder ZepfDUERBHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Getsch + Hiller Medizintechnik GMBHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Gimmi GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Guangzhou Red Pine Medical Instrument Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guenter Stoffel Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Guangdong MacroLux Medical Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
H.+H. Maslanka Chirurgische Instrumente GmbHTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hangzhou Endo Medical Instrument Co.,ltdhangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Kangji Medical Instrument Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Tonglu Shikonghou Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Horizons Intl. Corp.Heredia, Costa RicaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Iaa Surgical Instruments CoSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jiangsu Changmei Medtech Co.,ltdChangzhou Jiangsu, ChinaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Grit Medical Technology Co., Ltd.changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Kangjin Medical Instrument Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Power-Endo Medical Technology Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.Ji 'an Jiangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Josef Bacher GMBHRietheim-Weilheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kapp Surgical GMBHDUERBHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
LiNA Medical ApSNaerum Hovedstaden, DenmarkSpecification developer0000api.fda.gov
LiNA Medical Polska sp. z o.oTarnowo Podgorne Wielkopolskie, PolandManufacturer0000api.fda.gov
Macrolux Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Meditalia S.R.L..Palermo, ItalyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
Newtrans International CompanyNashville, TN, United StatesSpecification developer0000api.fda.gov
Ningbo Xinwell Medical Technology Co., Ltd.Cixi Zhejiang, ChinaManufacturer0000api.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
Optimedi Co., Ltd.Goyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
PMS GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Promisemed Hangzhou Meditech Co.,ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Raimund Wenzler GMBH, Instrumenten-ManufakturBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Reda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Sensorendo Medical Technology (zhuhai) Co., Ltd.Zhuhai Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
SIMMANK GmbH & Co.KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer, Specification developer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
Surtex Instruments LtdLondon Surrey, United KingdomManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Taewoong Medical Co., LtdGimpo-Si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
THD SPACorreggio Reggio Emilia, ItalyManufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Exporter to the US0000api.fda.gov
Trewavis Surgical Instruments Pty Ltd.Bayswater Victoria, AustraliaManufacturer0000api.fda.gov
Trokamed GMBHGEISINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer0000api.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
United States Endoscopy Group, Inc.Mentor, OH, United StatesManufacturer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Weba Medizintechnik GMBH & Co.BALGHEIM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Wilson Instruments (sha) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Soudon Medical Technology Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhuji Pengtian Medical Instrument Co.,Ltd.Zhuji Zhejiang, ChinaManufacturer0000api.fda.gov

Updated July 16, 2003. 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.