16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYVIOLENE(TM) SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EZPass™
FDA UDI
Biomet Orthopedics, LLC·00887868511035·
EZ PASS
FDA UDI
Biomet Orthopedics, LLC·00880304563759·
EZ PASS 70 DEGREE LEFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWQ·February 2, 2018
EZ PASS 70 DEGREE LEFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWQ·February 2, 2018
KESTREL LENS CASE 1543-893S/P-1700-2611
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Neurology
EZ PASS 70 DEGREE LEFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWQ·February 2, 2018
EZ PASS 70 DEGREE LEFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWQ·December 19, 2017
EZ PASS 70 DEGREE LEFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWQ·December 19, 2017
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 25, 2014
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·January 3, 2013
TOTALCARE SPO2RT
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 12, 2010
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
EZ PASS 30 DEGREE LEFT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HWQ·May 7, 2018
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
FDA Recall
Terminated
·Biomet, Inc.·Product code HWQ·April 15, 2014