MedtechSourcebook

Rongeur, Manual (HAE) contract manufacturers

10 US facilities list FDA product code HAE as a contract manufacturer (7) or contract sterilizer (3).

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

FDA device name
Rongeur, Manual
Product code
HAE (FDA product classification database)
Device class
Class II
Regulation
21 CFR 882.4840
Classification panel
Neurology

Where they are

Illinois 2 · Texas 2 · California 1 · Hawaii 1 · Massachusetts 1 · Michigan 1 · Puerto Rico 1 · Rhode Island 1

All 10 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
A&M BIOMEDICAL INC.2951215Contract manufacturerCardiovascular; Neurology; Obstetrics and gynecology +2 moreLaguna Hills, CANot verifiedOct 21, 2026
CONTECH MEDICAL, INC.1221541Contract manufacturerDental; Neurology; General and plastic surgeryProvidence, RINot verifiedOct 21, 2026
ISOMEDIX OPERATIONS INC.1220477Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreNorthborough, MANot verifiedOct 21, 2026
Instrumed International Inc dba Avalign German Specialty Instruments1421101Contract manufacturerGeneral and plastic surgery; Ear, nose and throat; Orthopedic +9 moreSchaumburg, ILNot verifiedOct 21, 2026
Isomedix Operations, Inc.1450662Contract sterilizerOrthopedic; General and plastic surgery; Cardiovascular +11 moreLibertyville, ILNot verifiedOct 21, 2026
MAINSTREAM MEDICAL DEVICES3016112537Contract manufacturerOrthopedic; General and plastic surgery; Cardiovascular +4 moreAustin, TXNot verifiedOct 21, 2026
PACIFIC INSTRUMENTS INC.3005641619Contract manufacturerOrthopedic; General and plastic surgery; Dental +5 moreHonolulu, HINot verifiedOct 21, 2026
PACKAGING COMPLIANCE MEDICAL, LLC3014967969Contract manufacturerOrthopedic; General and plastic surgery; Gastroenterology and urology +6 moreKentwood, MINot verifiedOct 21, 2026
STRYKER PUERTO RICO, LLC.2648666Contract manufacturerOrthopedic; General and plastic surgery; Ear, nose and throat +2 moreArroyo, PRNot verifiedOct 21, 2026
Sterigenics US LLC1649518Contract sterilizerOrthopedic; General and plastic surgery; General hospital +13 moreFort Worth, TXNot verifiedOct 21, 2026

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