7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONHAWA Respiratory Humidifier
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTOMED 3000 INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 18, 2011
ZIMMER AIR DERMATOME II HANDPIECE
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code GFD·July 10, 2013
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026