24 results · 27ms · Sources: EU EUDAMED, US FDA

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FLEX Vessel Prep System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM

APEX Flex - Standard Pink

FDA UDI
Sprintray, Inc.·00850070544597·SprintRay Apex Flex is an alternative to tradit...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM

6202187

FDA Adverse Event
Malfunction ·December 23, 2016

PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304

FDA 510(k)
FDA Class 2 ·Cardiovascular

RII INFRARED EAR THERMOMETER,

FDA 510(k)
FDA Class 2 ·General Hospital

ACCU-CHEK AVIVA PLUS TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·March 25, 2021

ACCU-CHEK ® PERFORMA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·June 7, 2021

ACCU-CHEK PERFORMA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·June 7, 2021

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 1, 2018

RESTORE ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 16, 2008

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011

UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL S.A·Product code GFA·June 28, 2013

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Death ·HEARTWARE, INC.·Product code DSQ·February 24, 2022

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·February 24, 2022

UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·May 16, 2024

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·December 18, 2023