Flambeau Medical’s Quality Management System QMS is FDA compliant and certified to:
ISO9001:2015, ISO13485:2016 and CFR21 820 standards.
Services We Provide
For over 65 years, Flambeau has provided quality plastic components and assemblies for the world’s largest OEM’s and startups. With a dozen manufacturing plants worldwide providing injection molding and blow molding solutions, we support your needs.
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Success Stories
Markets We Supply
Orthopedics
• Over-molded Cannulas
• Skeletal alignment systems
• Pedicle screws and rods
Drug Delivery
• IV infusion housings
• Peristaltic pump components
• Infusion pump components
Cardiovascular Tools
• Cardiovascular stimulant devices
• Cardiovascular power supply components
• Cardiovascular monitoring devices
Fluid Management
• Real-time fluid monitoring devices
• Urological connectors and components
• Fluidics and tube management systems
Diagnostics
• Assays for drug development
• Bioanalysis components/assemblies
• Shrouds and housings
Dental
• Vacuum control valves
• Connectors and fittings
• Dental component assembly
Sterile Packaging
• Sterile pouches and backer cards
• Sterile trays and Tyvek lids
• Sterile tubes and caps
Surgical Devices
• FDA Class I, II, III
• Minimally-invasive instruments
• Dexterous surgical tools