Approvals + Certifications

Departments - Regulatory

B. Braun FDA 510(k); ICU Medical obtains certification; Pulse Systems’ ISO 13485 and ISO 9001 certifications have been updated;

August 8, 2018

B. Braun, FDA 510(k) clearance for Perfusor Space Syringe Pump – the first syringe pump cleared for air and road transport.

The addition to the Synchronized Intelligence Infusion Platform offers the same user interface, wireless technology, and interoperability, and integrates with DoseTrac, DoseGuard, and AutoComplete Integrated EMR technology. This platform helps clinicians achieve 100% drug library compliance while minimizing medication errors and risks.

Medical device manufacturer ICU Medical Inc. has obtained certification under the UL Cybersecurity Assurance Program (UL CAP), which minimizes risks by creating standardized, testable criteria for assessing software vulnerabilities and weaknesses to reduce exploitation, enhance security controls, and address known malware and potential zero-day vulnerabilities.

ICU Medical earned UL CAP certification for its Plum 360 drug infusion system that provides interoperability with patient electronic health records (EHR), reducing the need for manual input and transcription of infusion data.

Pulse Systems ISO 13485 and ISO 9001 certifications have been updated to the ISO 13485:2016 and ISO 9001:2015 standards – the most recent revisions of manufacturing quality standards issued by the International Organization for Standardization (ISO).

Pulse Systems has been certified under ISO 13485 continuously since 2009.

Mahe Medical USA’s universal spine emergency screw removal system (ESR):

  • Removes broken, stripped screws without additional kits, hardware
  • Removes spine screw systems regardless of manufacturer
  • Uses fewer components, takes up less space in the operating room (OR), reduces possibility of mix-ups during procedures
  • Is a universal extractor, OR team doesn’t need to know individual hardware manufacturers

The system provides quicker and more certain extractions with a single wrench capable of removing any screw.