483
Pulsar Scientific LLCFDA 483 - Pulsar Scientific LLC - May 06, 2026
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Record Details
An FDA inspection of Pulsar Scientific LLC, a medical device manufacturer in Ludlow, MA, identified one significant observation. The firm failed to submit required Unique Device Identifier (UDI) information to the FDA's Global Unique Device Identification Database (GUDID) for its Recovery+ thermal compression system prior to commercial distribution. This indicates a lapse in regulatory compliance regarding device identification.
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