Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion
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Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)Safety Labeling Change Orders
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.F.H. Investments Inc dba Asteria Health. Birmingham, AL. 483 issued 12/19/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) F.H. Investments Inc dba Asteria Health. Birmingham, AL. 483 issued 12/19/2025
FEI Number 3038253438
Firm Name F.H. Investments Inc dba Asteria Health
Record Type 483
State AL
EsStudy of Sex Differences in the Clinical Evaluation of Medical Products
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