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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 9 | September 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 7 | September 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 6 | September 20, 2023 | 0 | 1 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 6 | July 29, 2020 | 0 | 3 | 0 | api.fda.gov |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 5 | August 17, 2012 | 0 | 2 | 0 | api.fda.gov |
| Lexion Medical, LLC. | Saint Paul, MN, United States | Manufacturer | 4 | August 28, 2019 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 2 | March 4, 2016 | 0 | 0 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 2 | February 5, 2004 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Remanufacturer, Repackager or relabeler | 1 | September 3, 1993 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 1 | December 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| Core Access Surgical Technologies, Inc. | Atlanta, GA, United States | Complaint file establishment, Specification developer | 1 | February 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 1 | February 3, 1999 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 1 | February 3, 1999 | 0 | 0 | 0 | api.fda.gov |
| Freyja Healthcare, LLC | Boston, MA, United States | Specification developer | 1 | May 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | November 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| NBS Group Supply- Medical Products Division, LLC | New Brunswick, NJ, United States | Specification developer | 1 | June 14, 2000 | 0 | 0 | 0 | api.fda.gov |
| RG Medical USA | Mount Juliet, TN, United States | Repackager or relabeler, Specification developer | 1 | January 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | January 24, 2003 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 1 | August 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | February 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | February 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demetech Corp. | Miami Lakes, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Santa Clara, CA, United States | Complaint file establishment, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Peachtree Corners, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Phoenix, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myriad Fiber Imaging Technologies, Inc. | Dudley, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novaprobe Inc. | Lansdale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.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.