Data / Medical devices / Laparoscope, General & Plastic Surgery / United States
FDA-registered makers of Laparoscope, General & Plastic Surgery in the United States: 146 establishments
146 establishments in the United States are registered with the FDA to make Laparoscope, General & Plastic Surgery (product code GCJ). 88 have a 510(k) clearance or PMA approval on file and 16 have a recall event. FDA data exported November 2, 2026.
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- Device
- Laparoscope, General & Plastic Surgery
- Product code
- GCJ
- Country
- United States
Makers of Laparoscope, General & Plastic Surgery in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Covidien | North Haven, CT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 56 | June 27, 2022 | 0 | 4 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 41 | February 18, 2026 | 0 | 10 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | 39 | February 19, 2021 | 0 | 3 | 0 | api.fda.gov |
| Covidien | Ponce, PR, United States | Contract manufacturer, Manufacturer | 34 | October 18, 2016 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 25 | February 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 20 | March 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 19 | November 1, 2023 | 0 | 10 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 18 | November 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 17 | October 14, 2026 | 0 | 1 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 16 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 15 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 13 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 12 | October 20, 2022 | 0 | 2 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 12 | April 9, 2020 | 0 | 4 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 11 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 10 | August 17, 2017 | 0 | 1 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | March 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 10 | February 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 9 | October 1, 2012 | 0 | 5 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 9 | October 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 7 | November 12, 2014 | 0 | 2 | 0 | api.fda.gov |
| Micromedics, Inc. | Saint Paul, MN, United States | Manufacturer | 6 | July 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| NDS Surgical Imaging, LLC. | Sarasota, FL, United States | Manufacturer, Specification developer | 5 | October 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xenocor, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 5 | February 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arthrex California Technology, Incorporated | Santa Barbara, CA, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer | 4 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Repackager or relabeler | 4 | February 15, 2002 | 0 | 1 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 4 | September 11, 2012 | 0 | 0 | 0 | api.fda.gov |
| Microline Surgical, Inc | Beverly, MA, United States | Complaint file establishment, Manufacturer | 4 | April 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Santa Barbara Imaging Systems | Goleta, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 4 | February 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 3 | October 30, 2003 | 0 | 0 | 0 | api.fda.gov |
| Flexbar Machine Corp. | Islandia, NY, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | December 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| Lsi Solutions Inc. | Victor, NY, United States | Manufacturer | 3 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Maquet Cardiovascular LLC | Wayne, NJ, United States | Manufacturer, Specification developer | 3 | April 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| RG Medical USA | Mount Juliet, TN, United States | Repackager or relabeler, Specification developer | 3 | August 23, 1994 | 0 | 0 | 0 | api.fda.gov |
| Sharp Fluidics, Inc. | El Granada, CA, United States | Complaint file establishment, Specification developer | 3 | November 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | May 12, 2010 | 0 | 1 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 2 | July 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer, Manufacturer | 2 | December 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 2 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| C2Dx, Inc. | Schoolcraft, MI, United States | Complaint file establishment, Manufacturer | 2 | December 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Dannik | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | March 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 2 | March 16, 1995 | 0 | 3 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 2 | August 9, 2005 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer, Specification developer | 2 | August 9, 2005 | 0 | 0 | 0 | api.fda.gov |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 2 | August 23, 1994 | 0 | 0 | 0 | api.fda.gov |
| Schoelly Usa Inc. | Northborough, MA, United States | Manufacturer | 2 | December 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Silex Medical, LLC | Southington, CT, United States | Manufacturer | 2 | January 26, 1995 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 2 | April 23, 1997 | 0 | 0 | 0 | api.fda.gov |
| Transamerican Technologies International | San Ramon, CA, United States | Manufacturer | 2 | February 14, 1994 | 0 | 0 | 0 | api.fda.gov |
| Anchor Products Co. | Addison, IL, United States | Manufacturer | 1 | September 23, 2009 | 0 | 1 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | September 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Activ Surgical Inc | Boston, MA, United States | Complaint file establishment, Manufacturer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 1 | July 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 1 | April 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 1 | January 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 1 | June 4, 2004 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Clearcam | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | August 24, 1993 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Elmed, Inc. | Glendale Heights, IL, United States | Manufacturer, Repackager or relabeler | 1 | March 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, LLC | Guaynabo, PR, United States | Manufacturer | 1 | October 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Freyja Healthcare, LLC | Boston, MA, United States | Specification developer | 1 | October 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | March 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| I.C. Medical, Inc. | Phoenix, AZ, United States | Manufacturer | 1 | October 7, 1995 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | November 28, 1983 | 0 | 0 | 0 | api.fda.gov |
| Integrated Endoscopy, Inc. | Irvine, CA, United States | Manufacturer | 1 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer | 1 | July 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Kronner Prototypes, Inc. | Roseburg, OR, United States | Manufacturer | 1 | May 2, 2000 | 0 | 0 | 0 | api.fda.gov |
| Lexington Medical, Inc. | Bedford, MA, United States | Complaint file establishment, Specification developer | 1 | March 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Lazurite Inc. | Cleveland, OH, United States | Manufacturer | 1 | March 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | July 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| National Advanced Endoscopy Devices, Inc. | Canoga Park, CA, United States | Manufacturer, Repackager or relabeler | 1 | December 6, 1999 | 0 | 0 | 0 | api.fda.gov |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 1 | January 27, 1992 | 0 | 0 | 0 | api.fda.gov |
| Omec Medical NV Inc | Reno, NV, United States | Contract manufacturer, Manufacturer | 1 | June 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Parallel Robotics, LLC | Ann Arbor, MI, United States | Manufacturer | 1 | May 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Prosurg, Inc | San Jose, CA, United States | Manufacturer | 1 | April 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ranfac Corp. | Avon, MA, United States | Contract manufacturer, Manufacturer | 1 | July 11, 1995 | 0 | 0 | 0 | api.fda.gov |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | December 5, 1994 | 0 | 0 | 0 | api.fda.gov |
| Surgical Principals, Inc. - Spi | Tacoma, WA, United States | Specification developer | 1 | September 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Thermasolutions LLC. | White Bear Lake, MN, United States | Manufacturer | 1 | December 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Trocare, LLC | Houston, TX, United States | Specification developer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Inc. | Cincinnati, OH, United States | Specification developer | 1 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vascular Technology Incorporated | Nashua, NH, United States | Manufacturer | 1 | June 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Wexler Surgical, Inc. | Houston, TX, United States | Repackager or relabeler, Specification developer | 1 | May 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Xodus Medical, Inc. | New Kensington, PA, United States | Manufacturer | 1 | September 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Zinnanti Surgical Design Group Inc | Santa Cruz, CA, United States | Specification developer | 1 | June 25, 1993 | 0 | 0 | 0 | api.fda.gov |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 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 | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc. | Rochester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Wire Cut Company, Inc. | Valencia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dielectrics, Inc. | Chicopee, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Geotec, Inc. | Warwick, RI, 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 | |
| Henke Sass Wolf Of America, Inc. | Dudley, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intravu, Inc. | Redwood City, 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 | |
| Karl Storz Imaging, Inc. | Goleta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lexion Medical, LLC. | Saint Paul, MN, United States | 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 | |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M&L Precision Machining Inc. | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, 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 | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| NBS Group Supply- Medical Products Division, LLC | New Brunswick, NJ, United States | Specification developer | 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 | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ORIGAMI SURGICAL Inc. | Dover, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthoscan, Inc. | Scottsdale, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips-Medisize, LLC | New Richmond, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Medical Products, Inc. | Mountain City, TN, 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 | |
| PRO-TECH Design & Mfg, Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, 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 | |
| R.K. Manufacturing | Danbury, CT, 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 | |
| Samax Precision Inc. | Sunnyvale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supreme Screw Products | Plainview, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions - Chandler | Chandler, AZ, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions Lakeland | Lakeland, FL, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Veridiam, LLC | El Cajon, CA, 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 | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 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.