7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
FDA 510(k)
FDA Class 2
·Radiology
EMPOWR VVC TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·February 27, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 7, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 24, 2014
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018