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