51 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PASCAL LASER INDIRECT OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295017875·GLOBAL CAP HEAD DUOFIX HA PC SIZE 56 x 21
GLOBAL CAP
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295017851·GLOBAL CAP HEAD DUOFIX HA PC SIZE 56 x 18
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000738·
Logical G-Series Acetabular Shell
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215053864·
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
FDA 510(k)
FDA Class 2
·Ophthalmic
CIRCUIT TUBINGS WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
Trabecular Metal™
FDA UDI
Zimmer, Inc.·00889024130470·
VENTO Cup
FDA UDI
AMPLITUDE SAS·03701089513937·
CUSTOM PROXIMAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOMER PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JLB·August 1, 2012
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 2, 2012
CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code JWH·January 8, 2015
TAXUS® EXPRESS²®
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2011