7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
FDA 510(k)
FDA Class 1
·Dental
Sklar®
FDA UDI
SKLAR CORPORATION·10649111166570·MICRO NH CVD .6MM JAW 6"
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AKLARUS PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 31, 2013
ENDURON NEUT 56 OR 68ODX28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 31, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 3, 2014