300 results
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30ms
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Sources: EU EUDAMED, US FDA
LANCER PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POLYFLUX REVACLEAR
FDA UDI
GAMBRO RENAL PRODUCTS, INC.·07332414101695·Revaclear-Revaclear Max are indicated for the t...
ASP
FDA UDI
SEDATELEC·03760262490434·The ASP Original, Semi-Permanent Needle, is an ...
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
FDA 510(k)
FDA Class 2
·Dental
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
PERMANENT CAUTERY SPATULA
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·May 26, 2011
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·May 14, 2013
CAROTID WALLSTENT?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·September 23, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 11, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 11, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 28, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 28, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 9, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 21, 2012
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·December 26, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 23, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 10, 2012