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ThruPort Systems Embol-X Introducer Sheath

FDA UDI
Edwards Lifesciences LLC·00690103192049·EMBOL-X INTRODUCER SHEATH

EXI TRANSPONDER

FDA Adverse Event
Injury ·EXI·March 18, 1999

EXI XFIX DYNAFIX

FDA Adverse Event
Malfunction ·ELECTRO-BIOLOGY, INC.·Product code HTY·March 13, 1998

OLYMPUS EXIS EXERA COLONOVIDEOSCOPE

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·February 13, 2009

MOMENTUM EL ICD DR

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·June 20, 2019

TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IOR·December 23, 2014

EEA

FDA Adverse Event
Malfunction ·US SURGICAL PUERTO RICO·Product code GDW·April 22, 2020

AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code FZX·October 29, 2014

EVIS EXERA III XENON LIGHT SOURCE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code NWB·September 17, 2021

PEDIATRIC URINE COLLECTOR BAG

FDA Adverse Event
Malfunction ·PRECISION DYNAMICS CORPORATION·Product code EXI·May 11, 2020

ARTIFICIAL URINARY SPHINCTER

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code EXY·March 27, 1997

CONVEEN SECURITY SSU 035

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code EXI·April 21, 2011

FIZE KUO DISPOSABLE PEDIATRIC KIT

FDA Adverse Event
Malfunction ·FIZE MEDICAL LTD.·Product code EXY·January 7, 2026

STEP FREE

FDA Adverse Event
Malfunction ·TIMM MEDICAL TECHNOLOGIES INC·Product code EXI·July 6, 2001

Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·March 25, 2015

POLIGRIP EX CREAM

FDA Adverse Event
Other ·GLAXOSMITHKLINE·Product code KOL·June 15, 2009

SURGIDAC

FDA Adverse Event
Malfunction ·DAVIS & GECK CARIBE LTD·Product code OCW·November 28, 2018

ENDO STITCH

FDA Adverse Event
Malfunction ·DAVIS & GECK CARIBE LTD·Product code OCW·November 28, 2018

COULTER LH 780

FDA Adverse Event
Other ·BECKMAN COULTER, INC.·Product code JJE·April 10, 2007

TI SPIRAL BLADE 60MM FOR TI RETROGRADE FEMORAL NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HSB·June 2, 2021