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Data / Medical devices / Unit, Cryosurgical, Accessories / United States

FDA-registered makers of Unit, Cryosurgical, Accessories in the United States: 30 establishments

30 establishments in the United States are registered with the FDA to make Unit, Cryosurgical, Accessories (product code GEH). 23 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 3, 2026.

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Device
Unit, Cryosurgical, Accessories
Product code
GEH
Country
United States

Makers of Unit, Cryosurgical, Accessories in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer17October 18, 2024030api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer17October 18, 2024000api.fda.gov
Cryoconcepts LPEaston, PA, United StatesManufacturer, Manufacturer for export, Specification developer16May 22, 2025000api.fda.gov
Varian Medical Systems, IncAustin, TX, United StatesManufacturer7March 28, 2023050api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer6February 9, 1994030api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer6November 6, 2024000api.fda.gov
Scholl's Wellness CompanyParsippany, NJ, United StatesComplaint file establishment, Specification developer6May 22, 2025000api.fda.gov
Atricure, Inc.Mason, OH, United StatesManufacturer5February 15, 2018020api.fda.gov
Cryosurgery, Inc.Nashville, TN, United StatesManufacturer5October 16, 2025000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesSpecification developer4December 2, 2022000api.fda.gov
AtriCure - MinneapolisMinnetonka, MN, United StatesSpecification developer2March 22, 2016000api.fda.gov
DGI Group LLCLakewood, NJ, United StatesComplaint file establishment, Manufacturer2May 18, 2023000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer2February 7, 2008000api.fda.gov
Nuance Medical, LLCCarlsbad, CA, United StatesManufacturer2July 12, 2016000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesRepackager or relabeler, Specification developer2October 6, 2010010api.fda.gov
Serpex Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer2September 2, 2026000api.fda.gov
Aso LLCSarasota, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1June 5, 2013000api.fda.gov
Brymill CorporationEllington, CT, United StatesManufacturer1March 25, 2020000api.fda.gov
Cool Renewal, LLCNashville, TN, United StatesManufacturer1July 6, 2016000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer1September 2, 1992000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1July 24, 2024000api.fda.gov
Mira, Inc.Uxbridge, MA, United StatesManufacturer1November 1, 1976000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1February 26, 2019000api.fda.gov
CSA MedicalLexington, MA, United StatesManufacturer for export0020api.fda.gov
EigenGrass Valley, CA, United StatesManufacturer0000api.fda.gov
Hubot, Inc.South Bend, IN, United StatesContract manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Stryker Corp.Kalamazoo, MI, United StatesContract manufacturer0000api.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.