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Data / Medical devices / Laparoscope, General & Plastic Surgery

Laparoscope, General & Plastic Surgery (GCJ): 346 FDA-registered makers in 32 countries

346 establishments in 32 countries are registered with the FDA to make Laparoscope, General & Plastic Surgery (product code GCJ, Class 2, 21 CFR 876.1500). 182 of them have a 510(k) clearance or PMA approval on file and 22 have a recall event. The FDA has issued 1,431 510(k) clearances under this code, the latest on October 14, 2026, and lists 94 recall events (2 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
GCJ
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States146
Germany64
China36
Mexico19
Japan14
Israel8
Taiwan7
France6
United Kingdom5
South Korea5
Canada3
Switzerland3
Dominican Republic2
Costa Rica2
Australia2
Italy2
Pakistan2
Malaysia2
Singapore2
Guatemala2
Thailand2
Bulgaria2
Turkey1
Belgium1
Ireland1
Indonesia1
Netherlands1
Estonia1
Malta1
Hong Kong1
Czechia1
Poland1

Makers of Laparoscope, General & Plastic Surgery

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
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer56June 27, 2022040api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer52September 1, 2026000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer41February 18, 20260100api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler39February 19, 2021030api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer34October 18, 2016000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicManufacturer31June 27, 2022000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer25February 19, 2021000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer20March 8, 2017000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer19November 1, 20230100api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer18November 1, 2023000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer17October 14, 2026010api.fda.gov
Sanmed Medikal Otomotiv Tekstil Ticaret Limited SirketiIstanbul, TurkeyExporter to the US, Manufacturer17June 27, 2022000api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Specification developer16July 8, 2020000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer15October 20, 2022000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer14May 14, 2008000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer13October 16, 2025000api.fda.gov
SoproLA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer13April 1, 2009000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer12October 20, 2022020api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer12April 9, 2020040api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler11April 9, 2020000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer10February 20, 2018000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer10August 17, 2017010api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer, Specification developer10March 9, 2022000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanExporter to the US, Specification developer10August 26, 2026000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler10February 1, 2016000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer9October 1, 2012050api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer9October 1, 2012000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer, Manufacturer8January 21, 2015000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer7November 12, 2014020api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer7April 3, 2020000api.fda.gov
Guangdong Optomedic Technologies, Inc.Foshan Guangdong, ChinaManufacturer6October 29, 2025000api.fda.gov
Humantouch Surgical Ltd.Netanya Central, IsraelComplaint file establishment, Manufacturer6June 5, 2023000api.fda.gov
Micromedics, Inc.Saint Paul, MN, United StatesManufacturer6July 15, 2024000api.fda.gov
Surgical Innovations LtdLeeds, United KingdomManufacturer6June 18, 2021030api.fda.gov
Sony CorporationYokohama-shi Kanagawa, JapanComplaint file establishment, Specification developer6August 26, 2026000api.fda.gov
Arthrex GmbHMunich Bavaria, GermanyExporter to the US, Specification developer5July 25, 2024000api.fda.gov
LG Electronics Inc.Gumi-si Gyeongbuk, South KoreaExporter to the US, Manufacturer5July 17, 2026000api.fda.gov
LG Electronics Nanjing New Technology Co., Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer5July 17, 2026000api.fda.gov
NDS Surgical Imaging, LLC.Sarasota, FL, United StatesManufacturer, Specification developer5October 19, 2022000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer5April 3, 2020000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler5February 20, 2007000api.fda.gov
Xenocor, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer5February 12, 2026000api.fda.gov
Arthrex California Technology, IncorporatedSanta Barbara, CA, United StatesContract manufacturer, Contract sterilizer, Manufacturer, Specification developer4October 16, 2025000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer, Repackager or relabeler4February 15, 2002010api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer4September 11, 2012000api.fda.gov
Microline Surgical, IncBeverly, MA, United StatesComplaint file establishment, Manufacturer4April 29, 2019000api.fda.gov
Nordson MEDICAL MexicoGuaymas Sonora, MexicoContract manufacturer, Exporter to the US4January 8, 2013000api.fda.gov
Novadaq Technologies ULCBurnaby British Columbia, CanadaComplaint file establishment, Manufacturer, Specification developer4November 21, 2018010api.fda.gov
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer4April 16, 2009000api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer4February 28, 2023000api.fda.gov
AB Medica SASMery Sur Cher Centre-Val de Loire, FranceManufacturer, Repackager or relabeler3January 23, 2026000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler3October 30, 2003000api.fda.gov
Flexbar Machine Corp.Islandia, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer3December 11, 2013000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanContract manufacturer, Manufacturer3December 2, 2021000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer3December 2, 2021000api.fda.gov
Intuitive Surgical, S. de R.L. de C.V.Mexicali Baja California, MexicoExporter to the US, Manufacturer3July 14, 2026000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer3January 12, 2024000api.fda.gov
Maquet Cardiovascular LLCWayne, NJ, United StatesManufacturer, Specification developer3April 15, 2020000api.fda.gov
RG Medical USAMount Juliet, TN, United StatesRepackager or relabeler, Specification developer3August 23, 1994000api.fda.gov
Schoelly Fiberoptic, GMBHDENZLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer3June 20, 2024000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer3January 13, 2023000api.fda.gov
Sharp Fluidics, Inc.El Granada, CA, United StatesComplaint file establishment, Specification developer3November 8, 2018000api.fda.gov
Taiwan Surgical CorporationZhubei City Hsinchu(County), TaiwanManufacturer3June 2, 2026000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer3May 12, 2010010api.fda.gov
Unimax Medical Systems Inc.New Taipei City, TaiwanExporter to the US, Specification developer3October 17, 2011010api.fda.gov
Unimax Medical Systems Inc.Yilan County, TaiwanManufacturer3October 17, 2011000api.fda.gov
Unimicro Medical Systems (shenzhen) Co., Ltd.ShenZhen Guangdong, ChinaManufacturer3August 10, 2015000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer2July 5, 2024000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesContract manufacturer, Manufacturer2December 18, 1998000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2February 10, 1997000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer2February 10, 1997000api.fda.gov
C2Dx, Inc.Schoolcraft, MI, United StatesComplaint file establishment, Manufacturer2December 15, 2014000api.fda.gov
DannikOrlando, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2March 12, 2025000api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI, United StatesComplaint file establishment, Specification developer2March 16, 1995030api.fda.gov
Eizo CorporationHAKUSAN Ishikawa, JapanManufacturer2September 11, 2026000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer2August 9, 2005000api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesManufacturer, Specification developer2August 9, 2005000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer2June 30, 2021000api.fda.gov
Lagis Enterprise Co., Ltd.Dajia Dist, Taichung City, TaiwanManufacturer2March 17, 2025000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer2August 23, 1994000api.fda.gov
Mitaka Kohki Co., Ltd.MITAKA SHI Tokyo, JapanContract manufacturer, Manufacturer2July 6, 2009000api.fda.gov
Schoelly Usa Inc.Northborough, MA, United StatesManufacturer2December 5, 2014000api.fda.gov
Silex Medical, LLCSouthington, CT, United StatesManufacturer2January 26, 1995000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer2April 23, 1997000api.fda.gov
Transamerican Technologies InternationalSan Ramon, CA, United StatesManufacturer2February 14, 1994000api.fda.gov
Zhuhai Dipu Medical Technology Co., Ltd.Zhuhai Guangdong, ChinaManufacturer2June 26, 2024000api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1April 21, 1998000api.fda.gov
Advanced Medical Design Co., Ltd.New Taipei City, TaiwanManufacturer1July 30, 2021000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer1January 30, 2002000api.fda.gov
Anchor Products Co.Addison, IL, United StatesManufacturer1September 23, 2009010api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer1January 30, 2002000api.fda.gov
Ark SurgicalNazareth Haifa, IsraelManufacturer1August 25, 2022000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1September 23, 1993000api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer1April 29, 1993000api.fda.gov
AVENT S. de R.L. de C.V.NOGALES Sonora, MexicoManufacturer1April 29, 1994000api.fda.gov
Activ Surgical IncBoston, MA, United StatesComplaint file establishment, Manufacturer1May 16, 1994000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer1July 5, 2019000api.fda.gov
Asclepion Laser Technologies GmbHJena Thuringia, GermanyManufacturer1November 6, 2024000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1April 29, 1994000api.fda.gov
Barco N.V.KORTRIJK West-Vlaanderen, BelgiumManufacturer1December 13, 2024000api.fda.gov
Baxter Healthcare CorporationRound Lake, IL, United StatesComplaint file establishment, Specification developer1January 8, 2020000api.fda.gov
Beijing Biosis Healing Biological Technology Co., LtdBeijing, ChinaManufacturer1August 6, 2020000api.fda.gov
Beijing Hangtian Kadi Technology R&D InstituteBeijing, ChinaManufacturer1February 1, 2018000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer1June 4, 2004000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1February 10, 1997000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1February 10, 1997000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer1February 10, 1997000api.fda.gov
ClearcamAustin, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1February 19, 2020000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1August 24, 1993000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler1August 24, 1993000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer, Manufacturer1July 8, 2020000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer1May 16, 1994000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler1March 22, 2019000api.fda.gov
Endoclot Plus Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1January 18, 2017000api.fda.gov
EndocontrolLa Tronche Isere, FranceManufacturer1December 18, 2008000api.fda.gov
Ethicon, Inc.CIUDAD JUAREZ Chihuahua, MexicoManufacturer1October 25, 1996000api.fda.gov
Ethicon, LLCGuaynabo, PR, United StatesManufacturer1October 25, 1996000api.fda.gov
Fengh Medical Co., Ltd.Jiangyin Jiangsu, ChinaManufacturer1April 9, 2018000api.fda.gov
Freyja Healthcare, LLCBoston, MA, United StatesSpecification developer1October 20, 2025000api.fda.gov
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JapanSpecification developer1March 10, 2017000api.fda.gov
Fannin UK LtdClevedon North Somerset, United KingdomManufacturer1September 26, 2011010api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer1March 7, 2018000api.fda.gov
Guangzhou T.K Medical Instrument Co., Ltd.Guangzhou Guangdong, ChinaManufacturer1July 9, 2020000api.fda.gov
Global Medical Production Co. LtdJiaXing Zhejiang, ChinaManufacturer1June 6, 2011000api.fda.gov
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1January 29, 2026000api.fda.gov
Hangzhou Kangji Medical Instrument Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer1April 9, 2024000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Repackager or relabeler1September 8, 1995000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1May 16, 1994000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer, Repackager or relabeler1July 29, 2005000api.fda.gov
Hunan Endoso Life Technology Co., LtdXiangTan Hunan, ChinaManufacturer1October 16, 2023000api.fda.gov
I.C. Medical, Inc.Phoenix, AZ, United StatesManufacturer1October 7, 1995000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1November 28, 1983000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer1November 28, 1983000api.fda.gov
Incore Co., Ltd.Daegu, South KoreaManufacturer1June 21, 2022000api.fda.gov
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer1May 22, 2008000api.fda.gov
Integrated Endoscopy, Inc.Irvine, CA, United StatesManufacturer1November 20, 2025000api.fda.gov
Intuitive Surgical Optics GmbHFreiburg Baden-Wurttemberg, GermanyManufacturer1October 14, 2026000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer1July 14, 2026000api.fda.gov
Jiangsu Haize Medical Scientific Development Co.,Ltd.Wuxi Jiangsu, ChinaManufacturer1June 24, 2016000api.fda.gov
Kronner Prototypes, Inc.Roseburg, OR, United StatesManufacturer1May 2, 2000000api.fda.gov
Lexington Medical, Inc.Bedford, MA, United StatesComplaint file establishment, Specification developer1March 27, 2018000api.fda.gov
Lumenis, Ltd.YOKNEAM Northern, IsraelManufacturer, Specification developer1March 31, 2005021api.fda.gov
Lazurite Inc.Cleveland, OH, United StatesManufacturer1March 23, 2022000api.fda.gov
Livac Pty LtdHawthorn Victoria, AustraliaSpecification developer1October 20, 2016000api.fda.gov
LivsMed Inc.Seongnam-si Gyeonggi, South KoreaManufacturer1December 3, 2021000api.fda.gov
Med Contact GMBHBurladingen-Salmendingen Baden-Wurttemberg, GermanySpecification developer1November 29, 1994000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer1July 19, 2006000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1July 19, 2006000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer1May 16, 1994000api.fda.gov
Nanjing Jusha Display Technology Co., LtdNanjing Jiangsu, ChinaManufacturer1May 31, 2019000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler1December 6, 1999000api.fda.gov
Novatech S.A.LA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer1March 13, 2017000api.fda.gov
Northgate Technologies Inc.Elgin, IL, United StatesComplaint file establishment, Manufacturer1January 27, 1992000api.fda.gov
Omec Medical NV IncReno, NV, United StatesContract manufacturer, Manufacturer1June 22, 2020000api.fda.gov
Parallel Robotics, LLCAnn Arbor, MI, United StatesManufacturer1May 24, 2026000api.fda.gov
PlasmaticaRaAnana Tel Aviv, IsraelManufacturer, Repackager or relabeler, Specification developer1September 12, 2022000api.fda.gov
PT. Team Metal IndonesiaBATAM Riau, IndonesiaContract manufacturer, Manufacturer1January 9, 1992000api.fda.gov
Prosurg, IncSan Jose, CA, United StatesManufacturer1April 29, 2016000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer1July 11, 1995000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer1December 5, 1994000api.fda.gov
ScopixAmikam Northern, IsraelManufacturer1April 8, 2026000api.fda.gov
Shenzhen Sophway Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1October 2, 2025000api.fda.gov
Sidam SRLMirandola Modena, ItalyManufacturer1July 31, 2020000api.fda.gov
Surgical Principals, Inc. - SpiTacoma, WA, United StatesSpecification developer1September 22, 2025000api.fda.gov
Shanghai Xodus Medical Company LimitedShanghai, ChinaManufacturer1September 19, 2018000api.fda.gov
Sinolinks Medical Innovation, Inc.ChangZhou Jiangsu, ChinaComplaint file establishment, Manufacturer1July 11, 2025000api.fda.gov
T.A. Walthem & CompanySialkot Punjab, PakistanManufacturer1January 22, 2016000api.fda.gov
T.A.G. Medical Products Corporation LtdGAATON Northern, IsraelManufacturer1April 28, 2023000api.fda.gov
Thermasolutions LLC.White Bear Lake, MN, United StatesManufacturer1December 6, 2022000api.fda.gov
Tianjin Uwell Medical Device Manufacturing Co LtdTianjin, ChinaManufacturer1January 11, 2017000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Exporter to the US1July 19, 2006000api.fda.gov
Trocare, LLCHouston, TX, United StatesSpecification developer1October 4, 2024000api.fda.gov
Trokamed GMBHGEISINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1July 19, 2006000api.fda.gov
Teleflex Medical Inc.Cincinnati, OH, United StatesSpecification developer1April 9, 2020000api.fda.gov
Vascular Technology IncorporatedNashua, NH, United StatesManufacturer1June 4, 2014000api.fda.gov
Vernacare Ltd.Chorley Lancashire, United KingdomManufacturer1March 4, 2004000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer, Manufacturer1November 29, 2016000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer1November 29, 2016000api.fda.gov
Wexler Surgical, Inc.Houston, TX, United StatesRepackager or relabeler, Specification developer1May 10, 2011000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesManufacturer1September 19, 2018000api.fda.gov
Xpan Inc.Vaughan Ontario, CanadaComplaint file establishment, Specification developer1June 2, 2023000api.fda.gov
Zinnanti Surgical Design Group IncSanta Cruz, CA, United StatesSpecification developer1June 25, 1993000api.fda.gov
Almikro GMBH & Co. KGBad Krozingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer0000api.fda.gov
Alleima Karlsruhe GmbHKarlsruhe Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Altek Biotechnology CorporationHsinchu Hsinchu(City), TaiwanContract manufacturer0000api.fda.gov
Altek Medical Sdn. Bhd.Iskandar Puteri Johor, MalaysiaContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
B.Y. Medimor LtdTiberias Northern, IsraelContract manufacturer0000api.fda.gov
Bacher Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
BAK KOHLER Medical KGNEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Barco S.R.L.Saronno Varese, ItalyContract manufacturer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Beilun Plastech IncNingbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Bema-Gmbh & Co. KGEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bowa-Electronic GMBHGOMARINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Bruetsch Technology AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Barco (Suzhou) Healthcare Technology Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Boyd Weiler GmbH & Co. KGWeiler-Simmerberg Bavaria, GermanyContract manufacturer0000api.fda.gov
Carestream Health, Inc.Rochester, NY, United StatesContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Celestica Electronics (S) Pte Ltd.Singapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Comhuge Medical Wire And Harness Technology Co., LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaContract manufacturer0010api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
D&T Inc.Yuseong-gu Daejeon, South KoreaContract manufacturer0000api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Dongguan Honfield Precision Parts Co., LtdZhangmutou, Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Dufner Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dielectrics, Inc.Chicopee, MA, United StatesContract manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ethicon Endo-Surgery S.A. De C.V. Planta IiCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fibertech Co., Ltd.Sakura-shi Chiba, JapanContract manufacturer0000api.fda.gov
Fmi Medisch BVSchiedam Zuid-Holland, NetherlandsContract manufacturer0000api.fda.gov
Fong's Engineering & Manufacturing Private LimitedSingapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer0000api.fda.gov
Geomed Medizin-Technik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Getsch + Hiller Medizintechnik GMBHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Glaser AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Gordian SurgicalM.P. Misgav Northern, IsraelManufacturer0000api.fda.gov
Guenter Bissinger Medizintechnik GMBHTENINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Guenter Stoffel Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hangzhou Endo Medical Instrument Co.,ltdhangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Henke Sass Wolf Of America, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
HGR Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hupfer Metallwerke GMBH & Co. KGCoesfeld North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Infus Medical Co., Ltd.Khon Kaen Province, ThailandContract manufacturer0000api.fda.gov
Intravu, Inc.Redwood City, CA, United StatesManufacturer0000api.fda.gov
ItekCartago, Costa RicaContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Intuitive Surgical Bulgaria EOODParvomay Plovdiv, BulgariaManufacturer0000api.fda.gov
Intuitive Surgical Optics GmbHEmmendingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Intuitive Surgical, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
JR MontagearbeitenTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jr-Medizintechnik GMBH & Co KGLeibertingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jiangsu BANA Medical Technology Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Karl Klappenecker GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract 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
Karl Storz Video Endoscopy Estonia OueLaagri Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Koscher & Wuertz GMBHSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kunststoff Christel GMBH & Co. KGBad Durrheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Lexion Medical, LLC.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Life Science Logistics, LLCBrownsburg, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer0000api.fda.gov
M&L Precision Machining Inc.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Mauna Kea TechnologiesPARIS Ile-de-France, FranceManufacturer0000api.fda.gov
Max Hauser Suddeutsche Chirurgiemechanik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Microtek Medical Malta LimitedMosta, MaltaContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing Ltd.HENG LI, DONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong KongContract manufacturer0000api.fda.gov
Myriad Fiber Imaging Technologies, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
MediConcepts Technology (Shenzhen) Company LimitedShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoContract sterilizer, Manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
NBS Group Supply- Medical Products Division, LLCNew Brunswick, NJ, United StatesSpecification developer0000api.fda.gov
NDS Surgical Imaging, LLCLudwigsstadt Bavaria, GermanyContract manufacturer0000api.fda.gov
New Deantronics Taiwan Ltd.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Novanta Medical S.R.O.Prelouc Pardubicky Kraj, CzechiaContract manufacturer0000api.fda.gov
Novaprobe Inc.Lansdale, PA, United StatesManufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Novanta Medical GmbHLUDWIGSSTADT Bavaria, GermanyContract manufacturer0000api.fda.gov
Novanta Medical GmbHBerlin, GermanySpecification developer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer, Manufacturer for export0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Omec Thai Co.,ltd.Bang Bo District Samut Prakan, ThailandContract manufacturer0000api.fda.gov
ORIGAMI SURGICAL Inc.Dover, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Orthoscan, Inc.Scottsdale, AZ, United StatesManufacturer0000api.fda.gov
Olympus Winter & Ibe GmbHTELTOW Brandenburg, GermanyManufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Phillips-Medisize, LLCNew Richmond, WI, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer0000api.fda.gov
Purple Surgical International LimitedHerts England, United KingdomSpecification developer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Purple Surgical Manufacturing LimitedTaunton Somerset, United KingdomContract manufacturer0000api.fda.gov
Qingdao O-Mec Medical Technology Co., Ltd.Qingdao Shandong, ChinaContract manufacturer0000api.fda.gov
Qisda Electronics (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Rominger Medizintechnik GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Sabre Medical Pty LtdLane Cove West New South Wales, AustraliaContract manufacturer, Contract sterilizer0000api.fda.gov
Samax Precision Inc.Sunnyvale, CA, United StatesContract manufacturer0000api.fda.gov
Schoelly-Optix OodPanagyurishte Pazardzhik, BulgariaContract manufacturer0000api.fda.gov
Shenzhen El3imaging Medical Devices Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Shenzhen Jingxintai Houseware Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Sichuan Innovation Technology Co., Ltd.Chengdu Sichuan, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Steripack Medical Poland SP. Z O.O.Jelcz-Laskowice Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Steute Technologies GMBH & Co. KGLoehne North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Supreme Screw ProductsPlainview, NY, United StatesContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Surgnova Healthcare Technologies (zhejiang) Co., Ltd.Cixi Zhejiang, ChinaManufacturer0000api.fda.gov
Sony Global Manufacturing & Operations Corporation Kohda SiteNukata-gun Aichi, JapanContract manufacturer0000api.fda.gov
Springboard ManufacturingRancho Cordova, CA, United StatesContract manufacturer0000api.fda.gov
Strub Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer0000api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesReprocessor0000api.fda.gov
Stryker Sustainability Solutions LakelandLakeland, FL, United StatesReprocessor0000api.fda.gov
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesManufacturer0010api.fda.gov
Veridiam, LLCEl Cajon, CA, United StatesContract manufacturer0000api.fda.gov
Vomed Volzer Medizintechnik GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Vpix Medical, Inc.Jung-gu Daejeon, South KoreaManufacturer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
medi-G GMBHMesskirch Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
medi-plus Instrumente GmbHTUTTLINGEN-NENDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated October 14, 2026. 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.