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JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450182222·

ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HARDYDISK LEVOFLOXACIN, 5MCG

FDA 510(k)
FDA Class 2 ·Microbiology

TIP FOR DHS®/DCS® IMPACTOR (338.28)

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HWA·April 7, 2015

TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code JEY·April 29, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 3, 2011

SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER "S" TIP CATHETER FOR FEMORAL INSERT

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·July 21, 2008

Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code MBB·October 21, 2022

GLIDESHEATH

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019

GLIDESHEATH

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022

GLIDESHEATH

FDA Adverse Event
Death ·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022

INSYTE

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 22, 2026

GLIDESHEATH

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020

RADIFOCUS INTRODUCER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020