MedtechSourcebook

Lithotriptor, Electro-Hydraulic (FFK) contract manufacturers

6 US facilities list FDA product code FFK as a contract manufacturer (3) or contract sterilizer (3).

FDA-registered (openFDA, export of Oct 21, 2026)

FDA device name
Lithotriptor, Electro-Hydraulic
Product code
FFK (FDA product classification database)
Device class
Class II
Regulation
21 CFR 876.4480
Classification panel
Gastroenterology and urology

Where they are

Illinois 2 · Michigan 1 · Minnesota 1 · Ohio 1 · Pennsylvania 1

All 6 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
Isomedix Operations, Inc.2183744Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +13 moreMinneapolis, MNNot verifiedOct 21, 2026
LYNX Medical Pennsylvania2528981Contract sterilizerOrthopedic; Gastroenterology and urology; Cardiovascular +8 moreErie, PANot verifiedOct 21, 2026
Nissha Medical Technologies (Ohio), Inc.1519132Contract manufacturerGastroenterology and urology; Obstetrics and gynecology; General and plastic surgery +2 moreNorwalk, OHNot verifiedOct 21, 2026
RICHARD WOLF MEDICAL INSTRUMENTS CORP.1418479Contract manufacturerGastroenterology and urology; Obstetrics and gynecology; Orthopedic +4 moreVernon Hills, ILNot verifiedOct 21, 2026
Sterigenics US LLC1423662Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreGurnee, ILNot verifiedOct 21, 2026
SunMed Group Holdings, LLC1314417Contract manufacturerAnesthesiology; General hospital; Ear, nose and throat +5 moreGrand Rapids, MINot verifiedOct 21, 2026

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