34 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALIVECOR HEART MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925016620·GOLDMAN SMALL RIGHT ANGLE PICK
N/A
FDA UDI
Tyber Medical, LLC·M695M1304090·
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·September 18, 2014
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·September 2, 2014
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 14, 2026
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·September 30, 2014
DUAL TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 9, 2011
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022
INSPIRE 6 HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022
ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 30, 2013
INSPIRE 6
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL.·Product code DTZ·July 15, 2024
INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 17, 2018