8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Naviswiss Knee
FDA 510(k)
FDA Class 2
·Neurology
Universal Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233519·
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGIC INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 25, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018