9 results
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35ms
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Sources: EU EUDAMED, US FDA
DEDO SUCTION CANNULA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DD cubeX² ML
FDA UDI
Dental Direkt GmbH·EDDIG8540051·High translucent zirconia for the manufacture o...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209125067·
ARM-A-VIAL LV HEATER-BREATHING SYS
FDA 510(k)
FDA Class 2
·Anesthesiology
SELECTIVE STREPTOCOCCUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·April 17, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 5, 2010
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 26, 2012
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019