Halozyme Therapeutics, Inc. is one of 25384 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Halozyme Therapeutics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CUMULASE
1
Total
1
Cleared
0
Denied
Halozyme Therapeutics, Inc. is a drug delivery technology company with a manufacturing facility in San Diego, US. The company specializes in innovative solutions that improve patient treatment experiences through proprietary drug delivery platforms and devices.
Halozyme received 1 FDA 510(k) clearance from 1 total submission in the Obstetrics & Gynecology category. The company's regulatory activity dates to 2005. As a historical record, Halozyme has not received clearances in more than five years and is considered inactive in the 510(k) database.
The company's commercial portfolio includes FDA-approved products leveraging proprietary enzyme technology and custom-designed auto-injector devices. Halozyme's technology platforms support subcutaneous drug delivery and aim to reduce treatment burden for patients by converting lengthy infusions into convenient injections.
Explore the company's cleared device names, product codes, and clearance dates in the 510(k) database for complete regulatory history.
FDA 510(k) Regulatory Record - Halozyme Therapeutics, Inc.
1 devices