5 results
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6ms
·
Sources: EU EUDAMED, US FDA
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 21, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
MIM software; System, Image Processing, Radiological
FDA Enforcement
Class II
·Ongoing·MIM Software Inc·March 12, 2025
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·July 3, 2024