Medical Device Manufacturer · US , Lionville , PA

West Pharmaceutical Services, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2004
6
Total
6
Cleared
0
Denied

West Pharmaceutical Services, Inc. is a leading provider of innovative injectable solutions and packaging components for the pharmaceutical and medical device industries. The company specializes in drug containment and delivery systems, with a manufacturing facility in Lionville, US. West serves established and emerging drug developers worldwide, shipping approximately 43 billion components and devices annually across 50 global sites.

West has received 6 FDA 510(k) clearances from 6 total submissions, with all submissions focused on General Hospital devices. The company's regulatory activity spans from 2004 to 2024, demonstrating sustained innovation in injectable delivery systems. Recent cleared devices include safety systems, admixture devices, and reconstitution systems that support hospital pharmacy operations and patient safety.

West's product portfolio encompasses stoppers and seals for injectable packaging, syringe and cartridge components, self-injection devices, and containment solutions including proprietary polymer alternatives to glass. The company also provides contract manufacturing services including injection molding, assembly, and finished packaging across North America and Europe.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - West Pharmaceutical Services, Inc.
6 devices
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