830 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY SIGMA PS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POINT 4 TRANSLUCENT MODIFIED
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·May 2, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 26, 2012
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 13, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 7, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 16, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 23, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 28, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 27, 2012
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 17, 2012
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 7, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 10, 2010
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 16, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 8, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 26, 2011