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Data / Medical devices / Insufflator, Laparoscopic / United States

FDA-registered makers of Insufflator, Laparoscopic in the United States: 37 establishments

37 establishments in the United States are registered with the FDA to make Insufflator, Laparoscopic (product code HIF). 21 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Insufflator, Laparoscopic
Product code
HIF
Country
United States

Makers of Insufflator, Laparoscopic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler9September 22, 2025000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer7September 20, 2023000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer, Manufacturer for export6September 20, 2023010api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer6July 29, 2020030api.fda.gov
Northgate Technologies Inc.Elgin, IL, United StatesComplaint file establishment, Manufacturer5August 17, 2012020api.fda.gov
Lexion Medical, LLC.Saint Paul, MN, United StatesManufacturer4August 28, 2019000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer2March 4, 2016000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer2February 5, 2004000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler1September 3, 1993000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer1December 19, 2014000api.fda.gov
Core Access Surgical Technologies, Inc.Atlanta, GA, United StatesComplaint file establishment, Specification developer1February 23, 2022000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer1February 3, 1999000api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer1February 3, 1999000api.fda.gov
Freyja Healthcare, LLCBoston, MA, United StatesSpecification developer1May 2, 2024000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1November 16, 2011000api.fda.gov
NBS Group Supply- Medical Products Division, LLCNew Brunswick, NJ, United StatesSpecification developer1June 14, 2000000api.fda.gov
RG Medical USAMount Juliet, TN, United StatesRepackager or relabeler, Specification developer1January 25, 2008000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1January 24, 2003000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1August 17, 2012000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1February 22, 2001000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1February 22, 2001000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Demetech Corp.Miami Lakes, FL, United StatesContract manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Intuitive Surgical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Manufacturer for export0000api.fda.gov
Intuitive Surgical, Inc.Peachtree Corners, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Intuitive Surgical, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
Myriad Fiber Imaging Technologies, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Novaprobe Inc.Lansdale, PA, United StatesManufacturer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov

Updated November 2, 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.