830 results · 21ms · Sources: EU EUDAMED, 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