Data / Medical devices / Laparoscope, Gynecologic (And Accessories) / United States
FDA-registered makers of Laparoscope, Gynecologic (And Accessories) in the United States: 39 establishments
39 establishments in the United States are registered with the FDA to make Laparoscope, Gynecologic (And Accessories) (product code HET). 24 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Laparoscope, Gynecologic (And Accessories)
- Product code
- HET
- Country
- United States
Makers of Laparoscope, Gynecologic (And Accessories) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 6 | May 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 4 | August 24, 2006 | 0 | 1 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 4 | August 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 3 | October 9, 1998 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | October 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 3 | September 28, 1992 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ponce, PR, United States | Contract manufacturer, Manufacturer | 3 | September 28, 1992 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Manufacturer, Specification developer | 3 | December 16, 2008 | 0 | 1 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 2 | May 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | August 24, 1994 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | October 12, 1990 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | October 12, 1990 | 0 | 0 | 0 | api.fda.gov |
| Endoplus | Mundelein, IL, United States | Manufacturer | 1 | August 24, 1994 | 0 | 0 | 0 | api.fda.gov |
| Greensleeve Medical Corp. | Boerne, TX, United States | Manufacturer | 1 | January 30, 1997 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 1 | March 4, 2005 | 0 | 0 | 0 | api.fda.gov |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 1 | June 27, 1994 | 0 | 0 | 0 | api.fda.gov |
| Medtec Applications, Inc. | Glendale Heights, IL, United States | Manufacturer | 1 | July 1, 1996 | 0 | 0 | 0 | api.fda.gov |
| Medical Illumination International, Inc | Chatsworth, CA, United States | Manufacturer | 1 | October 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 1 | October 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 1 | August 9, 1996 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | September 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 1 | March 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Contract manufacturer, Manufacturer | 1 | April 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Usgi Medical | San Clemente, CA, United States | Manufacturer | 1 | July 31, 2006 | 0 | 0 | 0 | api.fda.gov |
| Elmed, Inc. | Glendale Heights, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Imaging, Inc. | Goleta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Logistics, LLC | Brownsburg, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Stamping Corporation | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OBP Medical Corporation | Lawrence, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRO-TECH Design & Mfg, Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenocor, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.