9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARX Viral Transport Media Collection and Transport System
FDA 510(k)
FDA Class 1
·Microbiology
ELMED
FDA UDI
ELMED INCORPORATED·00842180167629·ORTHO SELF RETAINING RETRACTOR; 9.25", 10MM SER...
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Infrared ear and forehead thermometer, model YI-100
FDA 510(k)
FDA Class 2
·General Hospital
ST360 SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ZIMMER SPINE, INC.·Product code KWP·November 11, 2008
JAGWIRE¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·September 1, 2011
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022