9 results
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19ms
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Sources: EU EUDAMED, US FDA
PRECISET AMMONIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CD HORIZON Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);
FDA 510(k)
FDA Class 2
·Orthopedic
PALINDROME SAPPHIRE 28/45KT VT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·February 11, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FPO·October 24, 2012
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·September 20, 2010
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
FDA Recall
Terminated
·Berchtold Corp.·Product code FWH·July 10, 2012
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
FDA Recall
Terminated
·Berchtold Corp.·Product code GDC·March 12, 2013
OPERON D850 Surgical Table Product Usage: Surgical Table
FDA Recall
Terminated
·Berchtold Corp.·Product code GDC·April 16, 2012