10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD
FDA UDI
Medos International Sàrl·10886705029280·PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braid...
NEXTGEN ALTIUS OCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLASMALITE PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·July 15, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025