MedtechSourcebook

System/Device, Pharmacy Compounding (NEP) contract manufacturers

15 US facilities list FDA product code NEP as a contract manufacturer (6) or contract sterilizer (9).

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

FDA device name
System/Device, Pharmacy Compounding
Product code
NEP (FDA product classification database)
Device class
Class II
Regulation
21 CFR 880.5440
Classification panel
General hospital

Where they are

California 4 · Illinois 3 · Pennsylvania 2 · Arkansas 1 · Colorado 1 · Michigan 1 · New York 1 · Ohio 1 · Oklahoma 1

All 15 facilities

CompanyFDA registrationEstablishment typeDevice categoriesCity and stateCertificationUpdated
ARxIUM, INC.3012205369Contract manufacturerGeneral hospitalBuffalo Grove, ILNot verifiedOct 21, 2026
B. BRAUN US DEVICE MANUFACTURING LLC2523676Contract manufacturerGeneral hospital; Anesthesiology; General and plastic surgery +6 moreAllentown, PANot verifiedOct 21, 2026
Biovire, Inc.3011292417Contract manufacturerGastroenterology and urology; General hospital; PathologyBrighton, MINot verifiedOct 21, 2026
CADENCE DEVICE, INC.3010659131Contract manufacturerOrthopedic; General hospital; General and plastic surgery +3 moreCranberry Township, PANot verifiedOct 21, 2026
MedXL1644312Contract sterilizerGeneral and plastic surgery; General hospital; Cardiovascular +9 moreArdmore, OKNot verifiedOct 21, 2026
PDV MedTech3008514120Contract manufacturerCardiovascular; Orthopedic; General hospital +2 moreMorgan Hill, CANot verifiedOct 21, 2026
PLEXUS CORP.3004105270Contract manufacturerCardiovascular; Clinical chemistry; General and plastic surgery +3 moreBuffalo Grove, ILNot verifiedOct 21, 2026
Sterigenics U.S. LLC2953359Contract sterilizerGeneral and plastic surgery; Orthopedic; Ophthalmic +11 moreHayward, CANot verifiedOct 21, 2026
Sterigenics U.S., LLC1319639Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +14 moreQueensbury, NYNot verifiedOct 21, 2026
Sterigenics U.S., LLC2029275Contract sterilizerGeneral and plastic surgery; Orthopedic; Cardiovascular +16 moreCorona, CANot verifiedOct 21, 2026
Sterigenics US LLC1423662Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreGurnee, ILNot verifiedOct 21, 2026
Sterigenics US LLC3002907620Contract sterilizerOrthopedic; General and plastic surgery; General hospital +12 moreWest Memphis, ARNot verifiedOct 21, 2026
Sterigenics US, LLC1526534Contract sterilizerOrthopedic; General and plastic surgery; General hospital +14 moreLewis Center, OHNot verifiedOct 21, 2026
Synergy Health AST, LLC2030598Contract sterilizerGeneral and plastic surgery; Cardiovascular; Clinical chemistry +10 moreSan Diego, CANot verifiedOct 21, 2026
Terumo BCT STERILIZATION SERVICES, Inc.1724474Contract sterilizerCardiovascular; General and plastic surgery; Gastroenterology and urology +6 moreLakewood, CONot verifiedOct 21, 2026

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